Mesalamine Capsule, Extended Release
Takeda Pharmaceuticals USA Inc.
Open FDA's page for this record- Discontinued date
- 09/16/2026
- Update type
- New
- Initial posting date
- 09/16/2026
- Package NDC
- 54092-191-12
- Generic name
- Mesalamine Capsule, Extended Release
- Contact info
- 877 825 3327
- Related info
- Product is anticipated to be available until December 31, 2027
- Update date
- 09/16/2026
- Dosage form
- Capsule, Extended Release
- Presentation
- Pentasa, Capsule, Extended Release, 500 mg (NDC 54092-191-12)
- Company name
- Takeda Pharmaceuticals USA Inc.
- Status
- To Be Discontinued
- Therapeutic category
- Gastroenterology
- Harmonized identifiers (openFDA)
- Application number
- NDA020049
- Brand name
- PENTASA
- Generic name
- MESALAMINE
- Manufacturer name
- Takeda Pharmaceuticals America, Inc.
- Product NDC
- 54092-191, 54092-189
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- MESALAMINE
- RxCUI
- 206791, 314092, 476362, 580286
- SPL ID
- 42661699-8fcc-40da-a05d-91906f9973e8
- SPL set ID
- e39d9a3d-5d3a-4bb6-aab1-fdbb2a598606
- Package NDC
- 54092-189-81, 54092-191-12
- Nui
- N0000175781, M0000971
- Pharm class epc
- Aminosalicylate [EPC]
- Pharm class cs
- Aminosalicylic Acids [CS]
- UNII
- 4Q81I59GXC