Muscular weakness
Drugs: CAMZYOS, BISOPROLOL, FUROSEMIDE +5
- Safetyreportversion
- 1
- Safetyreportid
- 26940067
- Primarysourcecountry
- EU
- Occurcountry
- EU
- Transmissiondateformat
- 102
- Transmissiondate
- 20260709
- Reporttype
- 1
- Serious
- 1
- Seriousnessdeath
- 2
- Seriousnesslifethreatening
- 2
- Seriousnesshospitalization
- 1
- Seriousnessdisabling
- 1
- Seriousnesscongenitalanomali
- 2
- Seriousnessother
- 2
- Receivedateformat
- 102
- Receivedate
- 20260630
- Receiptdateformat
- 102
- Receiptdate
- 20260630
- Fulfillexpeditecriteria
- 1
- Companynumb
- EU-BRISTOL-MYERS SQUIBB COMPANY-2026-071183
- Primarysource
- Reportercountry
- EU
- Qualification
- 1
- Sender
- Sendertype
- 6
- Senderorganization
- BRISTOL-MYERS SQUIBB COMPANY
- Receiver
- Receivertype
- 6
- Receiverorganization
- FDA
- Patient
- Patientonsetage
- 72
- Patientonsetageunit
- 801
- Patientagegroup
- 6
- Patientsex
- 2
- Reaction
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Muscular weakness
- Reactionoutcome
- 2
- Drug
- Drugcharacterization
- 1
- Medicinalproduct
- CAMZYOS
- Drugauthorizationnumb
- 214998
- Drugstructuredosagenumb
- 5
- Drugstructuredosageunit
- 003
- Drugseparatedosagenumb
- 1
- Drugdosageform
- Capsule
- Drugindication
- Hypertrophic cardiomyopathy
- Actiondrug
- 1
- Drugrecurreadministration
- 3
- Drugadditional
- 1
- Activesubstance
- Activesubstancename
- MAVACAMTEN
- Harmonized identifiers (openFDA)
- Application number
- NDA214998
- Brand name
- CAMZYOS
- Generic name
- MAVACAMTEN
- Manufacturer name
- Myokardia, Inc.
- Product NDC
- 73625-111, 73625-112, 73625-113, 73625-114
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- MAVACAMTEN
- RxCUI
- 2600872, 2600878, 2600880, 2600882, 2600884, 2600886, 2600888, 2600890
- SPL ID
- 85338960-904b-44df-908f-b74b62902779
- SPL set ID
- 669c936b-3ee6-4e36-8a22-79dd11b1255b
- Package NDC
- 73625-111-11, 73625-112-11, 73625-113-11, 73625-114-11
- Nui
- N0000194047, N0000194048
- Pharm class epc
- Cardiac Myosin Inhibitor [EPC]
- Pharm class moa
- Cardiac Myosin Inhibitors [MoA]
- UNII
- QX45B99R3J
- Drugcharacterization
- 1
- Medicinalproduct
- CAMZYOS
- Drugauthorizationnumb
- 214998
- Drugstructuredosagenumb
- 10
- Drugstructuredosageunit
- 003
- Drugseparatedosagenumb
- 1
- Drugdosageform
- Capsule
- Actiondrug
- 1
- Drugrecurreadministration
- 3
- Drugadditional
- 1
- Activesubstance
- Activesubstancename
- MAVACAMTEN
- Harmonized identifiers (openFDA)
- Application number
- NDA214998
- Brand name
- CAMZYOS
- Generic name
- MAVACAMTEN
- Manufacturer name
- Myokardia, Inc.
- Product NDC
- 73625-111, 73625-112, 73625-113, 73625-114
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- MAVACAMTEN
- RxCUI
- 2600872, 2600878, 2600880, 2600882, 2600884, 2600886, 2600888, 2600890
- SPL ID
- 85338960-904b-44df-908f-b74b62902779
- SPL set ID
- 669c936b-3ee6-4e36-8a22-79dd11b1255b
- Package NDC
- 73625-111-11, 73625-112-11, 73625-113-11, 73625-114-11
- Nui
- N0000194047, N0000194048
- Pharm class epc
- Cardiac Myosin Inhibitor [EPC]
- Pharm class moa
- Cardiac Myosin Inhibitors [MoA]
- UNII
- QX45B99R3J
- Drugcharacterization
- 1
- Medicinalproduct
- CAMZYOS
- Drugauthorizationnumb
- 214998
- Drugstructuredosagenumb
- 15
- Drugstructuredosageunit
- 003
- Drugseparatedosagenumb
- 1
- Drugdosagetext
- STRENGTH-15MG
- Drugdosageform
- Capsule
- Actiondrug
- 1
- Drugrecurreadministration
- 3
- Drugadditional
- 1
- Activesubstance
- Activesubstancename
- MAVACAMTEN
- Harmonized identifiers (openFDA)
- Application number
- NDA214998
- Brand name
- CAMZYOS
- Generic name
- MAVACAMTEN
- Manufacturer name
- Myokardia, Inc.
- Product NDC
- 73625-111, 73625-112, 73625-113, 73625-114
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- MAVACAMTEN
- RxCUI
- 2600872, 2600878, 2600880, 2600882, 2600884, 2600886, 2600888, 2600890
- SPL ID
- 85338960-904b-44df-908f-b74b62902779
- SPL set ID
- 669c936b-3ee6-4e36-8a22-79dd11b1255b
- Package NDC
- 73625-111-11, 73625-112-11, 73625-113-11, 73625-114-11
- Nui
- N0000194047, N0000194048
- Pharm class epc
- Cardiac Myosin Inhibitor [EPC]
- Pharm class moa
- Cardiac Myosin Inhibitors [MoA]
- UNII
- QX45B99R3J
- Drugcharacterization
- 2
- Medicinalproduct
- BISOPROLOL
- Drugseparatedosagenumb
- 1
- Drugindication
- Product used for unknown indication
- Actiondrug
- 5
- Drugadditional
- 3
- Activesubstance
- Activesubstancename
- BISOPROLOL
- Harmonized identifiers (openFDA)
- Application number
- ANDA218303, ANDA075474
- Brand name
- BISOPROLOL
- Generic name
- BISOPROLOL FUMARATE
- Manufacturer name
- Micro Labs Limited, TruPharma, LLC
- Product NDC
- 42571-470, 42571-471, 52817-270, 52817-271
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- BISOPROLOL FUMARATE
- RxCUI
- 854901, 854905
- SPL ID
- 4cbe74e3-3af3-2b98-e063-6294a90a1c2b, 2a9e4180-cb1c-f924-e063-6394a90a60c6
- SPL set ID
- c3ee566c-74c4-45f4-a947-526a7313e326, bba0bc2b-602f-4df1-a761-85bd3c80c7de
- Package NDC
- 42571-470-30, 42571-470-01, 42571-470-05, 42571-471-30, 42571-471-01, 42571-471-05, 52817-270-10, 52817-270-30, 52817-271-10, 52817-271-30
- UNII
- UR59KN573L
- Drugcharacterization
- 2
- Medicinalproduct
- FUROSEMIDE
- Drugseparatedosagenumb
- 1
- Drugindication
- Product used for unknown indication
- Actiondrug
- 5
- Drugadditional
- 3
- Activesubstance
- Activesubstancename
- FUROSEMIDE
- Harmonized identifiers (openFDA)
- Application number
- ANDA078010, ANDA213902, NDA209988, NDA016273, ANDA212174, ANDA214766, ANDA070434, ANDA070433, NDA018823, ANDA070086, ANDA202747, ANDA203428, ANDA212803, ANDA070017, NDA018569, NDA018902, NDA018413, ANDA077293, NDA018667, ANDA218188, ANDA216629, ANDA218831, ANDA215856, NDA018267, ANDA076796, ANDA217557, NDA217294, ANDA216860
- Brand name
- FUROSEMIDE, FUROSCIX, LASIX, LASIX ONYU
- Generic name
- FUROSEMIDE
- Manufacturer name
- Ipca Laboratories Limited, Gland Pharma Limited, scPharmaceuticals Inc., a wholly owned subsidiary of MannKind Corporation, Validus Pharmaceuticals LLC, Sagent Pharmaceuticals, Eugia US LLC, Hikma Pharmaceuticals USA Inc., Civica, Inc., Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., Meitheal Pharmaceuticals Inc., Accord Healthcare, Inc., Marlex Pharmaceuticals, Inc., Phlow Corporation, Chartwell RX, LLC, Leading Pharma, LLC, Maiva Pharma Private Limited, Avenacy Inc., Fresenius Kabi USA, LLC, Hospira, Inc., Micro Labs Limited, Rising Pharma Holdings, Inc., Granulation Technology, Inc., Aurobindo Pharma Limited, Devatis Inc., NorthStar Rx LLC, Baxter Healthcare Corporation, Solco Healthcare LLC, Camber Pharmaceuticals, Inc., SQ Innovation, Inc., Lifestar Pharma LLC
- Product NDC
- 83980-002, 83980-003, 83980-004, 68083-432, 68083-433, 68083-434, 71767-111, 71767-100, 30698-060, 30698-067, 30698-066, 25021-311, 55150-322, 55150-323, 55150-324, 25021-320, 0054-3294, 0054-4297, 0054-8297, 0054-4299, 0054-8299, 0054-4301, 0054-8301, 0054-3298, 72572-190, 23155-473, 71288-203, 16729-500, 16729-501, 16729-502, 10135-832, 10135-833, 10135-834, 81565-201, 62135-753, 62135-754, 69315-116, 69315-117, 69315-118, 73542-101 +47 more
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Substance name
- FUROSEMIDE
- RxCUI
- 197732, 310429, 313988, 1719286, 1719290, 1719291, 2621022, 2621028, 2747765, 2747769, 200801, 200809, 205732, 197730, 197731, 2683305, 2683306, 2725542, 2725546
- SPL ID
- 2ef79eb1-61e5-4697-9292-336ca5cf5116, e7bd6ac5-0b85-49a8-b4a3-131d95b1764a, 57ef4d44-0cc5-db23-e063-6294a90a50cc, 4002943d-0b4b-4ff0-e063-6394a90ae63b, 222ce48f-2856-4be2-b16f-6fca38c0dceb, 9bb2ffa4-0891-4197-a970-90b178bbfad9, 29372fb6-0fa1-4caf-a55f-451091c93390, bc62ddda-7639-4090-99f0-7dd4d13518f3, 4e63826f-f7be-4cc6-b21d-03aec09b9c5e, c14acada-333e-43bb-b1cf-81d569e3e918, b06d36f6-507c-4b04-b79d-d6370a30a551, 1cfab300-d796-6a68-e063-6394a90a73f9, 4bd1ae61-8ab9-342a-e063-6394a90af1d2, e70f323d-2e94-4824-bb92-d43013caa497, 31443d9b-3dee-5aa9-e063-6294a90adcfd, 445bfa17-a52c-4492-9dbc-94218b30c1db, dddc74d0-e63a-431b-a222-12c45bdc0c16, 1b3f2803-b618-4447-b5ac-cd2bdc7de3e8, 9804efac-5457-417a-8de7-a688467759c0, e598e8a6-c854-48f5-a412-fb6a6783774a, 4829e889-87d2-9d87-e063-6294a90a11cb, 458b3c62-666c-43f2-8feb-ee8e6cbe8931, 53a09c30-7295-4337-89a4-93d3748d6ea3, 54741cba-d4ee-617e-e063-6294a90ad1eb, a504ee4b-3995-45f2-898c-91116dd81d19, 64b3fb5f-3516-4e39-b74e-e0e402ed9c4d, 3469f9cc-315f-4799-adab-08db8e4b388d, ad1cb298-ee74-429e-81e5-82eb2e6bfd77, 981d5143-60cd-4987-9b47-dec24c10de42, b4c1ae97-0f6c-4ae1-858a-4e0ab8f1ce53, febcfbde-87d9-4c2f-819f-dfb4a04082f8, f49380e9-82e1-439c-8cef-668d44a8e1ca, 2ce6b13e-910d-7342-e063-6394a90a92ca, a67aa830-538d-4920-ac7e-9b4418362473, 242c202f-a1ee-46ed-a78f-65112d626d9f, d4f07f52-c316-401b-b852-a1b29e3570b8
- SPL set ID
- 0acd293b-ecab-4879-a8e7-cd1b76148f2a, 644704c0-e6a5-4804-bfa6-795c8f83aa7a, eac958dd-8d43-e44e-e053-2995a90a4d5e, 2c9b4d8f-0770-482d-a9e6-9c616a440b1a, d63c1277-dd7e-4d21-9e80-68143f55e2dc, 421aa6d5-623b-4dc2-abd5-bb9e7765bf37, d76bd85a-8e57-477e-9607-c9435f1e26fb, 9e493331-dddd-496e-abf8-61747fb67aba, 7ecaa5af-d186-4380-b105-e7e528f75cc7, 1b9117d5-0dd9-4577-a1fd-bb0aaf7e68ec, a2e3c748-28ce-4c50-a182-721912919840, f6f64972-714c-4ee9-8a5e-9ffcab41a73b, 4bd1b15e-354e-051f-e063-6294a90a3f3b, 08a44bdd-028d-41af-9d4e-70971b0bcc4e, 8ebd2f10-acfc-48a4-a5db-f20377bda9ce, b5c6fcf4-fd37-4fee-8dac-1a3273d95ffe, e5880bf4-5037-4813-b7cc-656a6832ecb5, 7d0db0f7-bf4f-4b0b-9359-2a838626e04b, 3747bbcd-783d-4baa-bb5b-b6827bf390e3, aaced7a8-c3d7-4d66-8c07-aa407b8b3f35, 2f547f7c-0322-465c-9764-43f955d98ab2, 6101b9b4-f3ef-438e-a857-b4ea55ffc679, 3aadaca7-3661-4bfe-87f8-6368e4ab6536, 462e8917-cbe0-f4f9-e063-6394a90ab4ff, a504ee4b-3995-45f2-898c-91116dd81d19, c794c95a-654e-48fe-9596-201fc122ff75, c90bcb14-eb8d-4753-b339-3469c664ecd2, fc3194a3-7e75-4551-8334-4a5cc22d9f8b, 39fd32f2-6bb7-4a65-d298-e48d26bc80c7, c71371a7-75c5-45b8-b762-8d782d4c71bc, ddfc41a9-37d4-49c1-bbf3-969a98cd649c, 6a0fb397-63ae-4fce-bddf-16a91b1b7a2f, f6221cce-e586-4002-bd14-6ec22eb14e2e, cb27654f-c7a1-4796-ab08-60a5fa16f5c0, 6d9caaab-d874-4cf1-b9fe-408452a18998, 92f3ab5d-361c-4e12-bb50-fd4a9f195a8f
- Package NDC
- 83980-002-97, 83980-002-01, 83980-002-10, 83980-003-97, 83980-003-01, 83980-003-10, 83980-004-97, 83980-004-01, 83980-004-05, 83980-004-10, 68083-432-05, 68083-432-25, 68083-433-05, 68083-433-25, 68083-434-05, 68083-434-25, 71767-111-01, 71767-100-01, 30698-067-01, 30698-067-10, 30698-060-01, 30698-060-10, 30698-060-50, 30698-066-05, 30698-066-50, 25021-311-02, 25021-311-04, 25021-311-10, 55150-322-01, 55150-322-25, 55150-323-01, 55150-323-25, 55150-324-01, 55150-324-25, 25021-320-02, 25021-320-04, 25021-320-10, 0054-4297-31, 0054-4297-25, 0054-8297-25 +170 more
- Nui
- N0000175366, N0000175590
- Pharm class pe
- Increased Diuresis at Loop of Henle [PE]
- Pharm class epc
- Loop Diuretic [EPC]
- UNII
- 7LXU5N7ZO5
- Drugcharacterization
- 2
- Medicinalproduct
- LEVOTHYROXINE SODIUM
- Drugseparatedosagenumb
- 1
- Drugindication
- Product used for unknown indication
- Actiondrug
- 5
- Drugadditional
- 3
- Activesubstance
- Activesubstancename
- LEVOTHYROXINE SODIUM
- Harmonized identifiers (openFDA)
- Application number
- ANDA209713, ANDA216414, ANDA215259, NDA021292, NDA021924, ANDA212399, ANDA208749, NDA202231, NDA021342, NDA021210, NDA210632, ANDA211417, ANDA076187, ANDA216729, NDA021301, ANDA206163, NDA214047, ANDA217066, NDA021402, NDA214253, NDA206977, ANDA207588
- Brand name
- LEVOTHYROXINE SODIUM, EUTHYROX, TIROSINT, LEVOXYL, UNITHROID, THYQUIDITY, SYNTHROID, TIROSINT SOL
- Generic name
- LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS
- Manufacturer name
- Lupin Pharmaceuticals, Inc., Aurobindo Pharma Limited, XLCare Pharmaceuticals, Inc., Provell Pharmaceuticals, LLC, IBSA Pharma Inc., Camber Pharmaceuticals, Inc., Accord Healthcare Inc., Sagent Pharmaceuticals, Fresenius Kabi USA, LLC, Lannett Company, Inc, Amneal Pharmaceuticals NY LLC, NorthStar RxLLC, Mylan Pharmaceuticals Inc., Fosun Pharma USA Inc., ENDO USA, Inc., Pfizer Laboratories Div Pfizer Inc, Amneal Pharmaceuticals LLC, Piramal Critical Care, Inc., YARAL Pharma Inc., Oliva Therapeutics, LLC, Zydus Pharmaceuticals USA Inc., AbbVie Inc., Hikma Pharmaceuticals USA Inc., ONESOURCE SPECIALTY PHARMA LIMITED, Macleods Pharmaceuticals Limited, Teva Pharmaceuticals, Inc.
- Product NDC
- 68180-965, 68180-966, 68180-967, 68180-968, 68180-969, 68180-970, 68180-971, 68180-972, 68180-973, 68180-974, 68180-975, 68180-976, 59651-554, 59651-555, 59651-556, 59651-557, 59651-558, 72865-236, 72865-237, 72865-238, 72865-239, 72865-240, 72865-241, 72865-242, 72865-243, 72865-244, 72865-245, 72865-246, 72865-247, 72305-050, 72305-025, 72305-075, 72305-088, 72305-100, 72305-112, 72305-125, 72305-137, 72305-150, 72305-175, 72305-200 +195 more
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL, INTRAVENOUS
- Substance name
- LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS
- RxCUI
- 892246, 892251, 892255, 966220, 966221, 966222, 966224, 966225, 966248, 966249, 966253, 966270, 966153, 966160, 966166, 966173, 966177, 966182, 966187, 966196, 966202, 966207, 2104866, 905451, 905453, 905455, 905457, 905458, 905460, 905462, 905464, 966404, 966405, 966406, 966407, 966412, 966413, 966415, 966417, 966420 +87 more
- SPL ID
- 94052e3d-58b2-4f4b-8223-a47281c1a592, c760d0cc-2245-4914-8c67-d536c41ac90f, 16376b6d-2936-4208-ab94-3e0969dce769, 8b98dc0b-b9fa-42eb-81a0-07b4679d9332, 4ddc8742-bf50-baa5-e063-6294a90a56eb, 7c79df0b-836b-479b-a7a6-8e09b802a84e, 415fc774-31a5-124f-e063-6294a90a0e46, 2662e418-ef9b-40be-abbd-db71401e3c20, c2f1de80-e517-401f-9ef4-006545f79f9f, 47e50f93-a701-747e-e063-6294a90a5259, 3a92e520-3da8-43be-9be2-63511c44b735, b76cd786-4b5c-4f96-bbbf-a7399d50fb27, 09cdd46f-eae9-4faa-b3b3-67fcd71b62ff, 4512b948-0c89-43b8-a3c7-7ddef86d6178, ca193039-55b1-4a7e-aa67-c4bff4f9f5b0, 53ff60de-4131-c23e-e063-6394a90a34ba, 7e79776a-ca4b-49a9-8bc8-131c425c0bb2, e230c170-2a16-47d0-bce7-ac0414c192f7, 6514086f-834b-4c0c-82a1-c95338ef42a0, 35a7647b-9644-4c4c-8011-a0d5969c0a56, 3f9e1bbc-d3e2-c795-e063-6394a90aecdf, 74ccf7df-fab4-4a59-b7b9-eb531ec49c37, 4dde84bb-3bd3-6722-e063-6394a90a4c09, 390a4d8d-b481-0d9a-e063-6394a90a9b53, 2ef84f1a-cf9a-4e93-8b2b-08bf75befd9e, 1da8e5bc-aeb7-4168-a8c3-e1d9a9d167ea, b85ab7fa-ba96-43cd-b736-44b3924e644c, 563fecaf-128d-4f6b-81c8-715b4d90a261, 58da3dc9-3dea-30eb-e063-6294a90ad6ea, 3a77ca51-7d8a-4755-aabc-3801cc772a10, 4e04737b-8d88-7c75-e063-6394a90a34c0, 8f65417f-488f-4e4a-894c-56f99ed57d25
- SPL set ID
- 18717e58-89fb-4e2f-93b6-d6ac3e988d37, c760d0cc-2245-4914-8c67-d536c41ac90f, 51a27110-e787-409b-98ba-c6471d0ad5cf, bc3c6830-ba68-4ba3-9896-a12d0ad0b275, 7a7ade79-0165-4e31-b84e-667416c00c7e, b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e, a6233381-3043-4e9a-aaa6-a6b105e5142b, f57e9b19-6f17-4520-80fc-511322cc56c9, f88f44d8-2f18-4155-9d78-6323d19fbafe, a8db0f7d-8863-9309-e053-2995a90a284a, fca88c97-5cd4-4834-ba87-deb5bd637788, 50b1c8a4-75b6-49c8-80fc-3841ee80b183, 08f4b1f8-6807-47e7-bef8-8d1972aa0557, 58f4dc90-3648-49dc-a7e1-baf918a773b5, e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc, 3361138a-6e6f-e8df-e063-6294a90af2de, 9d815416-11c9-470e-a82f-89b0bf232e12, 758588c3-c63e-491b-0aa2-4f50d80cb174, 388a1f15-8c1c-46a5-997f-7f326f696b59, 07562e72-7eaa-4ce6-94f0-e08814787e50, 76139990-1355-cfb6-e053-2991aa0ace5b, 152d071f-d4aa-46d2-b397-61c1cabdd86d, d28d7202-1278-0486-e053-2995a90af286, 0c839877-50e4-455f-9b6c-462efb09cb96, bf8a952c-f05b-4814-b55a-ed04be015269, ce990712-49c1-4f66-9ee4-c770e8ec394c, 1e11ad30-1041-4520-10b0-8f9d30d30fcc, 6279390b-ee61-4ef9-ac15-25537ca783c1, ae9954a5-e196-449c-abea-ebe4afbee517, b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9, 5d378add-f13d-40f2-99dc-0f2340ab44b7, 60cadfd7-82b5-4207-97e1-1dd0655efb27
- Package NDC
- 68180-965-03, 68180-965-02, 68180-965-09, 68180-965-01, 68180-966-03, 68180-966-02, 68180-966-09, 68180-966-01, 68180-967-03, 68180-967-02, 68180-967-09, 68180-967-01, 68180-968-09, 68180-968-02, 68180-968-01, 68180-968-03, 68180-969-01, 68180-969-02, 68180-969-03, 68180-969-09, 68180-970-01, 68180-970-02, 68180-970-03, 68180-970-09, 68180-971-01, 68180-971-02, 68180-971-03, 68180-971-09, 68180-972-01, 68180-972-02, 68180-972-03, 68180-972-09, 68180-973-01, 68180-973-02, 68180-973-03, 68180-973-09, 68180-974-01, 68180-974-02, 68180-974-03, 68180-974-09 +577 more
- UNII
- 9J765S329G, 054I36CPMN
- Drugcharacterization
- 2
- Medicinalproduct
- PANTOPRAZOLE
- Drugseparatedosagenumb
- 1
- Drugdosagetext
- 20
- Drugindication
- Product used for unknown indication
- Actiondrug
- 5
- Drugadditional
- 3
- Activesubstance
- Activesubstancename
- PANTOPRAZOLE
- Harmonized identifiers (openFDA)
- Application number
- ANDA202882, ANDA205119, ANDA077619
- Brand name
- PANTOPRAZOLE SODIUM, PANTOPRAZOLE
- Generic name
- PANTOPRAZOLE
- Manufacturer name
- XLCare Pharmaceuticals Inc., Quallent Pharmaceuticals Health LLC, Amneal Pharmaceuticals LLC, Camber Pharmaceuticals, Inc., NorthStar RxLLC, Dr.Reddy's Laboratories Limited
- Product NDC
- 72865-229, 72865-230, 82009-010, 82009-011, 65162-636, 65162-637, 31722-712, 31722-713, 72603-177, 72603-178, 55111-332, 55111-333
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- PANTOPRAZOLE SODIUM
- RxCUI
- 251872, 314200
- SPL ID
- f26fc428-a419-1008-e053-2a95a90a83fc, 48430767-cec0-15e0-e063-6394a90ac032, 940df77d-5373-4196-946e-19271ac91087, 48f42a12-2eac-e5dd-e063-6294a90aa92d, 57338853-6995-de1e-62ca-be5505c8d656, c0575fc6-20c4-12a6-10b7-1af65cac1ee0
- SPL set ID
- 17468dbf-84b6-4c53-9ad5-341350d2cfab, 643eb498-d916-4fb7-9281-32895575ab36, f3ded82a-cf0d-4844-944a-75f9f9215ff0, 9daa1483-5a36-44db-9e0d-904d100da262, 82f0103a-2b97-d210-6d7d-c627d60ad694, 564709e8-358f-c185-4ecb-b3849c3fe59c
- Package NDC
- 72865-229-90, 72865-230-90, 72865-230-10, 82009-010-90, 82009-011-90, 82009-011-10, 65162-636-03, 65162-636-09, 65162-637-03, 65162-637-09, 65162-637-50, 65162-637-11, 31722-712-90, 31722-712-32, 31722-712-31, 31722-713-90, 31722-713-32, 31722-713-31, 31722-713-10, 72603-177-01, 72603-178-01, 55111-332-30, 55111-332-90, 55111-332-01, 55111-332-05, 55111-332-10, 55111-332-79, 55111-332-81, 55111-332-78, 55111-333-30, 55111-333-90, 55111-333-01, 55111-333-05, 55111-333-10, 55111-333-79, 55111-333-81, 55111-333-78
- UNII
- 6871619Q5X
- Drugcharacterization
- 2
- Medicinalproduct
- OLMESARTAN
- Drugseparatedosagenumb
- 1
- Drugdosagetext
- 10
- Drugindication
- Product used for unknown indication
- Actiondrug
- 5
- Drugadditional
- 3
- Activesubstance
- Activesubstancename
- OLMESARTAN
- Drugcharacterization
- 2
- Medicinalproduct
- ASPIRIN
- Drugseparatedosagenumb
- 1
- Drugindication
- Product used for unknown indication
- Actiondrug
- 5
- Drugadditional
- 3
- Activesubstance
- Activesubstancename
- ASPIRIN
- Harmonized identifiers (openFDA)
- Application number
- M013, M013.50, part343, M
- Brand name
- BAYER GENUINE ASPIRIN, ASPIRIN, ENTERIC ASPIRIN, ADULT LOW DOSE ASPIRIN, CHEWABLE ASPIRIN, DRUG MART EFFERVESCENT PAIN RELIEF, ASPIRIN LOW DOSE, ASPIRIN ENTERIC COATED, ASPIRIN 81, ADULT CHEWABLE ASPIRIN, ASPIRIN 81MG, ADULT LOW DOSE ENTERIC COATED ASPIRIN, ASPIRIN LOW DOSE SAFETY COATED, GERITREX ASPIRIN, BUFFERED ASPIRIN, ENTERIC COATED ASPIRIN, BUFFERIN REGULAR STRENGTH PAIN RELIEF, WISPIRIN, EQUATE ASPIRIN, LOW DOSE ASPIRIN, HEB EFFERVESCENT PAIN RELIEF, PAIN RELIEF ASPIRIN LOW DOSE, ASPIRIN 81 MG LOW DOSE, ASPIRIN EXTRA STRENGTH, BAYER CHEWABLE - ASPIRIN REGIMEN LOW DOSE ASPIRIN CHERRY FLAVORED, TRAVEL SAVVY ASPIRIN, CHEWABLE ASPIRIN 81 MG, TOPCARE ASPIRIN, RAPIDOL ASPIRIN, CAREALL ASPIRIN, ASPIRIN REGULAR STRENGTH, REGULAR STRENGTH ASPIRIN, LOW DOSE MINIPRIN ENTERIC SAFETY COATED, ASPIRIN DELAYED RELEASE, GOOD NEIGHBOR PHARMACY ASPIRIN, LEADER ASPIRIN, CHEWABLE LOW DOSE ASPIRIN, CIRCLE K ASPIRIN 325, LOW DOSE ASPIRIN ENTERIC SAFETY COATED, ASPIRIN 81MG ENTERIC COATED +90 more
- Generic name
- ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG
- Manufacturer name
- Unifirst First Aid Corporation, Health Pharma USA LLC, Topco Associates, LLC, Walgreen Company, CHAIN DRUG MARKETING ASSOCIATION INC, Advanced Rx LLC, Chain Drug Marketing Association, Inc., Discount Drug Mart Inc, STRATEGIC SOURCING SERVICES LLC, L.N.K. International, Inc., Grocery Outlet, Rising Pharma Holdings, Inc., HARRIS TEETER, BETTER LIVING BRANDS LLC., Bi-Mart, Trifecta Pharmaceuticals USA LLC, Marc Glassman, Inc., Care One (Retail Business Services, LLC.), Geritrex LLC, Cardinal Health 110, LLC. DBA Leader, DISCOUNT DRUG MART, Genomma Lab USA, Wisdrug AG, Wal-Mart Stores Inc, Advance Pharmaceutical Inc., P & L Development, LLC, H. E. BUTT GROCERY COMPANY, Rite Aid Corporation, Richmond Pharmaceuticals, Inc., Magno-Humphries, Inc., CHAIN DRUG MARKETING ASSOCIATION, INC., Time-Cap Labs, Inc, Bayer HealthCare LLC., Allegiant Health, Bellegrove Medical Supply, Inc., Padagis US LLC, United Natural Foods, Inc. dba UNFI, PROSTAT FIRST AID, HYVEE INC, Topco Associates LLC +120 more
- Product NDC
- 47682-456, 71679-302, 36800-545, 0363-0587, 63868-898, 80513-289, 83324-075, 53943-431, 70677-1121, 50844-600, 85828-372, 57237-302, 72036-252, 21130-428, 37835-571, 69396-173, 68998-146, 72476-263, 54162-940, 70000-0147, 53943-081, 50066-610, 87580-001, 49035-467, 17714-009, 59726-065, 37808-861, 70000-0253, 11822-0600, 54738-128, 54257-274, 83324-090, 49483-382, 0280-2090, 69168-318, 59961-616, 59961-620, 0574-7034, 17714-010, 41163-563 +291 more
- Product type
- HUMAN OTC DRUG
- Route
- ORAL, RECTAL
- Substance name
- ASPIRIN
- RxCUI
- 211874, 212033, 308416, 198467, 318272, 2606079, 260847, 198471, 825180, 198464, 1052678, 1600991, 387090, 212086, 794229, 1189781, 243670, 749795, 211832
- SPL ID
- 3e5d2e28-1c08-7a10-e063-6294a90a551e, 50385717-c87c-b515-e063-6394a90aa371, 035fcef2-398e-401b-90b2-33cf5b522c04, 808636ee-c838-423b-afd1-e719235ae38c, ac2d47b0-2641-4474-a8d3-bc1d362edbad, 38ec4680-85ec-6450-e063-6294a90aeb69, 8a5b018a-1a3c-4580-b858-70658250a261, 1c35f394-a222-6531-e063-6394a90acb8a, 24b274d6-f226-07eb-e063-6394a90a1d7d, 62d04705-d057-45a8-b5c3-18c9c82caa65, 2f13f7b8-33e5-4f1d-91f2-d210ed8c72d2, ffa0c51f-1493-4897-99cf-8ae6ab2a6f05, 58debf07-b093-bc03-e063-6294a90a28fa, 2d62fa1e-80f4-1f9e-e063-6394a90a575d, 31151537-fd19-b17e-e063-6394a90aad81, 372be4d6-cde3-c6a2-e063-6294a90a8825, 27d89e9f-7a2e-1bb8-e063-6394a90a4b4e, c1884ada-373c-47d9-8b7f-63b9d9067ac1, cc723205-04c3-410f-8fa1-93900afb9142, d10425d7-6e69-45d3-b91d-c02f5884923d, 249d869c-d17e-ebcb-e063-6394a90a94b6, 4f652a68-82a2-4c22-acc4-2cb28f96b358, 4e70ec5e-d034-a525-e063-6394a90a5a93, 07be5485-529c-4f12-ab56-55296f3691ee, 2a32783c-571f-26cb-e063-6394a90af066, 008ee85b-5cac-45a6-a857-a828f8125175, 285f424d-b50c-c734-e063-6394a90a9680, a5bb5d00-5da7-4488-8683-b4ae43a2125f, 03139c1b-6cee-4d3c-89dd-b07596d75ee7, 5cc44dca-00c9-b589-e053-2a91aa0a0521, 08bf7b4e-4f73-7538-e063-6394a90a6627, 1ac70227-c7c3-de60-e063-6394a90aeed7, 7d3ee158-5996-c9c6-e053-2991aa0a844a, 4526b3d0-3666-afe5-e063-6294a90af3ab, e6eab4fe-e1dc-4b80-9711-d4c74618eb4b, 3e5d63ea-c1b6-f7fc-e063-6394a90ae253, a6ca751c-7438-4a0f-adae-d176f73f4915, 5cc8b5f1-4ae4-471b-e053-2991aa0a84c1, 180c7e2b-b245-43e4-a26d-4e8b083d7a86, 3bdb9dec-858a-3145-e063-6394a90acd0d +276 more
- SPL set ID
- 356e4ff4-a7f1-4a50-9b86-2555e232b300, 503868bb-48e0-b718-e063-6394a90a9c5b, 56c125de-fabf-41fa-88a4-760d2793f202, 82cc404b-fcf5-4e48-ab1a-09d8c47f9e04, a791d664-99fe-4cba-95cf-f49baedde326, ad0d6a5c-eee9-406c-8d7f-1df9b45f5340, cc865351-34e8-4e8e-b8bf-23336c45bc61, 1c35f394-a221-6531-e063-6394a90acb8a, 2ca87a29-1f54-4da4-a66f-3b3dd4f0396c, 2f6ec676-3832-420e-be91-fce83f6586c8, 79c64e27-87aa-4081-8cbf-343768b00b90, bfc4fd55-45db-41f4-b878-a6b7155f0849, c6a28617-1769-7a7d-e053-2995a90a1ea0, f300dfbc-7137-79d1-e053-2995a90a636e, 08769966-2f6e-4fce-8391-ec1910ab5e7a, 372be427-acbd-c10c-e063-6294a90a572d, 3d519af3-9398-4439-8253-1e5d4612b8e3, 6659e103-fa03-4de0-af42-d2fbd548a87c, 93fb4359-c93d-46c4-b36e-611b829f514c, e5f68c1a-21f3-45a1-861f-229a95b3721c, 03ed19dd-1cfc-47d5-b83e-ffa2ebe93f48, 3543b2bf-1062-468a-a5dc-eabb2408af8c, 4e70ec5e-d033-a525-e063-6394a90a5a93, ea3f8eed-7b70-4156-9586-125d27bf29a8, f6a9ea44-08b8-4a33-bfbd-68cb2d852c39, 0058175f-3474-40c3-a046-6cfaec86d84b, 03876c71-60ec-3280-e063-6294a90a62dc, 318cc982-23a9-4804-b6fb-248f772d7a38, 503408ed-e799-48a0-8d38-3034f4a0ead5, 6a4c897d-c2a8-41b8-98b7-e7da8e2819ec, a7c02378-4213-4e57-aca2-2437ad02f786, bfb9af64-3195-44bf-bcf3-6b36b40d3cc7, efc7d42a-241a-422d-bc08-be2f5f774b62, 070d5713-e018-2913-e054-00144ff8d46c, 3ca60fa3-0a0c-4b3e-a0a2-da527ccf4fe5, bae80044-ad7f-3bf5-e053-2995a90a42f9, cce244aa-cd79-49c8-b68e-267f2bd0ef67, f2e7332a-bcd6-4aef-9e4c-a2cef5ea9464, 18b79449-5c4c-41ce-9609-80f5efa0375c, 3bdb9d89-9000-69f9-e063-6294a90a0c97 +276 more
- Package NDC
- 47682-456-50, 47682-456-47, 71679-302-00, 36800-545-60, 0363-0587-32, 0363-0587-14, 63868-898-10, 80513-289-03, 83324-075-36, 53943-431-36, 70677-1121-1, 50844-600-32, 50844-600-95, 50844-600-14, 50844-600-01, 50844-600-17, 85828-372-17, 57237-302-12, 57237-302-10, 72036-252-01, 21130-428-12, 21130-428-20, 37835-571-12, 37835-571-05, 69396-173-01, 68998-146-01, 72476-263-12, 72476-263-30, 54162-940-90, 70000-0147-1, 53943-081-02, 50066-610-13, 50066-610-30, 87580-001-01, 49035-467-68, 49035-467-08, 17714-009-36, 59726-065-30, 37808-861-36, 70000-0253-2 +615 more
- Nui
- N0000000160, N0000008836, M0001335, N0000175722, N0000175578, N0000008832
- Pharm class moa
- Cyclooxygenase Inhibitors [MoA]
- Pharm class pe
- Decreased Prostaglandin Production [PE], Decreased Platelet Aggregation [PE]
- Pharm class cs
- Anti-Inflammatory Agents, Non-Steroidal [CS]
- Pharm class epc
- Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]
- UNII
- R16CO5Y76E
- Drugcharacterization
- 2
- Medicinalproduct
- DESVENLAFAXINE
- Drugseparatedosagenumb
- 1
- Drugdosagetext
- 100
- Drugindication
- Product used for unknown indication
- Actiondrug
- 5
- Drugadditional
- 3
- Activesubstance
- Activesubstancename
- DESVENLAFAXINE
- Harmonized identifiers (openFDA)
- Application number
- ANDA204083, NDA204150, ANDA204805, ANDA204065, ANDA204003, ANDA210014, ANDA204028
- Brand name
- DESVENLAFAXINE
- Generic name
- DESVENLAFAXINE, DESVENLAFAXINE SUCCINATE
- Manufacturer name
- Hikma Pharmaceuticals USA Inc., Sun Pharmaceutical Industries, Inc., Marlex Pharmaceuticals, Inc., Alembic Pharmaceuticals Limited, Actavis Pharma, Inc., Slate Run Pharmaceuticals, LLC, Advagen Pharma Ltd, Breckenridge Pharmaceutical, Inc, NorthStar Rx LLC
- Product NDC
- 0054-0400, 0054-0603, 0054-0401, 63304-191, 63304-192, 10135-821, 10135-822, 46708-152, 46708-153, 0591-3659, 0591-4060, 0591-3660, 46708-540, 46708-541, 46708-542, 70436-012, 70436-013, 70436-036, 72888-143, 72888-175, 72888-144, 51991-006, 51991-311, 51991-312, 72603-555, 72603-556, 72603-557
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- DESVENLAFAXINE SUCCINATE, DESVENLAFAXINE
- RxCUI
- 1607617, 1874553, 1874559, 790264, 790288
- SPL ID
- c5148154-683f-4369-bb65-9f6f43a64e2b, cd04a0b2-a7f2-4629-997f-af2a8e65f15b, 387ce260-7ac6-36e8-e063-6394a90a4e49, 6ebe192e-2b88-43fc-a2c8-db2c42bc5a43, f5e72c18-96f8-4538-a238-8c72138bd6ce, 162ec8ed-f695-4db2-badf-4afb6b9e1cba, 4dfe07e0-b3f0-b219-e063-6394a90aa4dc, 598c3727-16e5-a206-e063-6294a90aadc9, 8e532045-4ca8-423d-a070-29b81fb0823f, 34888df6-f68d-c171-e063-6294a90a7604
- SPL set ID
- 662890ff-d254-40e0-a9fe-f07ab94d65d6, 91cf39c9-4d26-480a-a3a3-a3d8d4c4d222, 387cea91-6924-2a68-e063-6394a90a8f75, 9f74708c-6f6a-46cf-8c79-87a25c2bb6f8, 617476f9-62d7-40ef-a1b1-c349d4ad706f, 5bd203d2-477e-4d12-a875-cb8009f42410, 44f4b928-d5b8-44e7-bfa6-81fb0dc1a718, ff837eb1-24c3-4c63-9b4b-c6b5935a9b47, 25bdfc41-c7cb-4d16-b6a8-f102f9b8c984, 3fcc0555-f9cf-4735-a0ef-830c50c390b8
- Package NDC
- 0054-0603-13, 0054-0400-13, 0054-0400-22, 0054-0400-06, 0054-0400-29, 0054-0400-20, 0054-0401-06, 0054-0401-13, 0054-0401-22, 0054-0401-20, 63304-191-30, 63304-191-90, 63304-192-30, 63304-192-90, 10135-821-14, 10135-821-10, 10135-821-30, 10135-821-90, 10135-822-14, 10135-822-10, 10135-822-30, 10135-822-90, 46708-152-30, 46708-152-90, 46708-153-30, 46708-153-90, 0591-4060-30, 0591-3659-30, 0591-3660-30, 46708-540-17, 46708-540-30, 46708-540-90, 46708-540-31, 46708-540-91, 46708-540-10, 46708-540-80, 46708-541-17, 46708-541-30, 46708-541-90, 46708-541-31 +50 more
- UNII
- ZB22ENF0XR, NG99554ANW
- Nui
- N0000000102, N0000175749, N0000000109, N0000182137
- Pharm class moa
- Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]
- Pharm class epc
- Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
- Summary
- Narrativeincludeclinical
- CASE EVENT DATE: 20260614