Approvals (Drugs@FDA)

ZEPBOUND, ZEPBOUND KWIKPEN, ZEPBOUND (AUTOINJECTOR)

ELI LILLY AND CO · TIRZEPATIDE

NDA217806Drug (NDA)Prescription
Open FDA's page for this record
Application number
NDA217806
Sponsor name
ELI LILLY AND CO
Submissions
  1. Submission type
    SUPPL
    Submission number
    41
    Submission status
    AP
    Submission status date
    20260826
    Review priority
    STANDARD
    Submission class code
    EFFICACY
    Submission class code description
    Efficacy
    Application docs
    1. ID
      87059
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/217806Orig1s041correctedltr.pdf
      Date
      20260910
      Type
      Letter
    2. ID
      87180
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217806Orig1s041correctedlbl.pdf
      Date
      20260910
      Type
      Label
  2. Submission type
    SUPPL
    Submission number
    19
    Submission status
    AP
    Submission status date
    20241018
    Review priority
    901 REQUIRED
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      79930
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217806Orig1s005, 006, 011, 015, 019ltr.pdf
      Date
      20241021
      Type
      Letter
    2. ID
      79938
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s005s006s011s015s019lbl.pdf
      Date
      20241021
      Type
      Label
  3. Submission type
    SUPPL
    Submission number
    6
    Submission status
    AP
    Submission status date
    20241018
    Review priority
    STANDARD
    Submission class code
    EFFICACY
    Submission class code description
    Efficacy
    Application docs
    1. ID
      79925
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217806Orig1s005, 006, 011, 015, 019ltr.pdf
      Date
      20241021
      Type
      Letter
    2. ID
      79936
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s005s006s011s015s019lbl.pdf
      Date
      20241021
      Type
      Label
  4. Submission type
    SUPPL
    Submission number
    31
    Submission status
    AP
    Submission status date
    20250925
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      83542
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/217806Orig1s031ltr.pdf
      Date
      20250926
      Type
      Letter
    2. ID
      83555
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217806s031lbl.pdf
      Date
      20250926
      Type
      Label
  5. Submission type
    SUPPL
    Submission number
    15
    Submission status
    AP
    Submission status date
    20241018
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      79929
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217806Orig1s005, 006, 011, 015, 019ltr.pdf
      Date
      20241021
      Type
      Letter
    2. ID
      79952
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s005s006s011s015s019lbl.pdf
      Date
      20241021
      Type
      Label
  6. Submission type
    SUPPL
    Submission number
    2
    Submission status
    AP
    Submission status date
    20260120
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      84790
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/217806Orig1s002ltr.pdf
      Date
      20260121
      Type
      Letter
    2. ID
      84791
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/217806Orig1s002ltr.pdf
      Date
      20260121
      Type
      Letter
    3. ID
      84795
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217806s002lbl.pdf
      Date
      20260121
      Type
      Label
    4. ID
      84796
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217806s002lbl.pdf#page=34
      Date
      20260121
      Type
      Medication Guide
  7. Submission type
    SUPPL
    Submission number
    13
    Submission status
    AP
    Submission status date
    20241220
    Review priority
    PRIORITY
    Submission class code
    EFFICACY
    Submission class code description
    Efficacy
    Application docs
    1. ID
      80674
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s013lbl.pdf
      Date
      20241220
      Type
      Label
    2. ID
      80675
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s013lbl.pdf#page=32
      Date
      20241220
      Type
      Medication Guide
    3. ID
      80713
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217806Orig1s013ltr.pdf
      Date
      20241226
      Type
      Letter
    4. ID
      85860
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/217806Orig1s013.pdf
      Date
      20260511
      Type
      Review
  8. Submission type
    SUPPL
    Submission number
    11
    Submission status
    AP
    Submission status date
    20241018
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      79928
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217806Orig1s005, 006, 011, 015, 019ltr.pdf
      Date
      20241021
      Type
      Letter
    2. ID
      79937
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s005s006s011s015s019lbl.pdf
      Date
      20241021
      Type
      Label
  9. Submission type
    SUPPL
    Submission number
    50
    Submission status
    AP
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      87077
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217806Orig1s050lbl.pdf
      Date
      20260901
      Type
      Label
    2. ID
      87081
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/215866Orig1s052,217806Orig1s050ltr.pdf
      Date
      20260901
      Type
      Letter
    3. ID
      87091
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217806s041lbl.pdf#page=34
      Date
      20260901
      Type
      Medication Guide
  10. Submission type
    SUPPL
    Submission number
    42
    Submission status
    AP
    Submission status date
    20260225
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      85180
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/217806Orig1s042ltr.pdf
      Date
      20260227
      Type
      Letter
    2. ID
      85191
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217806s042lbl.pdf
      Date
      20260302
      Type
      Label
  11. Submission type
    SUPPL
    Submission number
    5
    Submission status
    AP
    Submission status date
    20241018
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      79926
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217806Orig1s005, 006, 011, 015, 019ltr.pdf
      Date
      20241021
      Type
      Letter
    2. ID
      79927
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217806Orig1s005, 006, 011, 015, 019ltr.pdf
      Date
      20241021
      Type
      Letter
    3. ID
      79935
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s005s006s011s015s019lbl.pdf
      Date
      20241021
      Type
      Label
  12. Submission type
    SUPPL
    Submission number
    3
    Submission status
    AP
    Submission status date
    20240328
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      78015
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s003lbl.pdf
      Date
      20240401
      Type
      Label
    2. ID
      78043
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217806Orig1s003Corrected_ltr.pdf
      Date
      20240403
      Type
      Letter
  13. +3 more not shown
Products
  1. Product number
    018
    Reference drug
    Yes
    Brand name
    ZEPBOUND
    Reference standard
    Yes
    Dosage form
    SOLUTION
    Route
    SUBCUTANEOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      TIRZEPATIDE
      Strength
      60MG/2.4ML (25MG/ML)
  2. Product number
    024
    Reference drug
    Yes
    Brand name
    ZEPBOUND KWIKPEN
    Reference standard
    Yes
    Dosage form
    SOLUTION
    Route
    SUBCUTANEOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      TIRZEPATIDE
      Strength
      60MG/2.4ML (25MG/ML)
  3. Product number
    016
    Reference drug
    Yes
    Brand name
    ZEPBOUND
    Reference standard
    Yes
    Dosage form
    SOLUTION
    Route
    SUBCUTANEOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      TIRZEPATIDE
      Strength
      40MG/2.4ML (16.7MG/ML)
  4. Product number
    008
    Reference drug
    Yes
    Brand name
    ZEPBOUND
    Reference standard
    Yes
    Dosage form
    SOLUTION
    Route
    SUBCUTANEOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      TIRZEPATIDE
      Strength
      5MG/0.5ML (5MG/0.5ML)
  5. Product number
    022
    Reference drug
    Yes
    Brand name
    ZEPBOUND KWIKPEN
    Reference standard
    Yes
    Dosage form
    SOLUTION
    Route
    SUBCUTANEOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      TIRZEPATIDE
      Strength
      40MG/2.4ML (16.7MG/ML)
  6. Product number
    014
    Reference drug
    Yes
    Brand name
    ZEPBOUND
    Reference standard
    Yes
    Dosage form
    SOLUTION
    Route
    SUBCUTANEOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      TIRZEPATIDE
      Strength
      20MG/2.4ML (8.33MG/ML)
  7. Product number
    006
    Reference drug
    Yes
    Brand name
    ZEPBOUND (AUTOINJECTOR)
    Reference standard
    Yes
    Dosage form
    SOLUTION
    Route
    SUBCUTANEOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      TIRZEPATIDE
      Strength
      15MG/0.5ML (15MG/0.5ML)
  8. Product number
    020
    Reference drug
    Yes
    Brand name
    ZEPBOUND KWIKPEN
    Reference standard
    Yes
    Dosage form
    SOLUTION
    Route
    SUBCUTANEOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      TIRZEPATIDE
      Strength
      20MG/2.4ML (8.33MG/ML)
  9. Product number
    012
    Reference drug
    Yes
    Brand name
    ZEPBOUND
    Reference standard
    Yes
    Dosage form
    SOLUTION
    Route
    SUBCUTANEOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      TIRZEPATIDE
      Strength
      15MG/0.5ML (15MG/0.5ML)
  10. Product number
    004
    Reference drug
    Yes
    Brand name
    ZEPBOUND (AUTOINJECTOR)
    Reference standard
    Yes
    Dosage form
    SOLUTION
    Route
    SUBCUTANEOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      TIRZEPATIDE
      Strength
      10MG/0.5ML (10MG/0.5ML)
  11. Product number
    010
    Reference drug
    Yes
    Brand name
    ZEPBOUND
    Reference standard
    Yes
    Dosage form
    SOLUTION
    Route
    SUBCUTANEOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      TIRZEPATIDE
      Strength
      10MG/0.5ML (10MG/0.5ML)
  12. Product number
    002
    Reference drug
    Yes
    Brand name
    ZEPBOUND (AUTOINJECTOR)
    Reference standard
    Yes
    Dosage form
    SOLUTION
    Route
    SUBCUTANEOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      TIRZEPATIDE
      Strength
      5MG/0.5ML (5MG/0.5ML)
  13. +12 more not shown
Harmonized identifiers (openFDA)
Application number
NDA217806
Brand name
ZEPBOUND, ZEPBOUND KWIKPEN
Generic name
TIRZEPATIDE
Manufacturer name
Eli Lilly and Company
Product NDC
0002-0152, 0002-2506, 0002-2495, 0002-2484, 0002-2471, 0002-2460, 0002-2457, 0002-0243, 0002-1214, 0002-1340, 0002-1423, 0002-2002, 0002-6052, 0002-6103, 0002-6210, 0002-6304, 0002-6523, 0002-6612, 0002-3566, 0002-3555, 0002-3544, 0002-3533, 0002-3522, 0002-3511
Product type
HUMAN PRESCRIPTION DRUG
Route
SUBCUTANEOUS
Substance name
TIRZEPATIDE
RxCUI
2601743, 2601755, 2601761, 2601767, 2601773, 2601784, 2644396, 2644401, 2644405, 2644409, 2644413, 2644417, 2669706, 2669709, 2669712, 2669715, 2669718, 2669721, 2679317, 2679319, 2679321, 2679323, 2679325, 2679327, 2732437, 2732440, 2732442, 2732444, 2732446, 2732448, 2732449, 2732450, 2732452, 2732454, 2732456, 2732458, 2734623, 2734626, 2734628, 2734630 +8 more
SPL ID
a5dba1a3-f7f7-4b8d-b9f1-a09dcdc1b2fc
SPL set ID
487cd7e7-434c-4925-99fa-aa80b1cc776b
Package NDC
0002-2506-01, 0002-2506-80, 0002-2506-61, 0002-2495-01, 0002-2495-80, 0002-2484-01, 0002-2484-80, 0002-2471-01, 0002-2471-80, 0002-2460-01, 0002-2460-80, 0002-2457-01, 0002-2457-80, 0002-0152-01, 0002-0152-04, 0002-0152-61, 0002-0243-01, 0002-0243-04, 0002-1214-01, 0002-1214-04, 0002-1340-01, 0002-1340-04, 0002-1423-01, 0002-1423-04, 0002-2002-01, 0002-2002-04, 0002-6052-01, 0002-6052-11, 0002-6103-01, 0002-6103-11, 0002-6210-01, 0002-6210-11, 0002-6304-01, 0002-6304-11, 0002-6523-01, 0002-6523-11, 0002-6612-01, 0002-6612-11, 0002-3566-01, 0002-3566-11 +11 more
Nui
N0000194015, N0000000152, N0000178480, N0000020058
Pharm class epc
Glucose-dependent Insulinotropic Polypeptide Receptor Agonist [EPC], GLP-1 Receptor Agonist [EPC]
Pharm class moa
G-Protein-linked Receptor Interactions [MoA], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
UNII
OYN3CCI6QE
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.