NDC 63304-089 – Mesalamine
Mesalamine 500 mg/1 · Capsule, Extended Release · Oral
Product NDC63304-089
Product details
- Brand name
- Mesalamine
- Generic name
- Mesalamine
- Labeler
- Sun Pharmaceutical Industries Inc.
- Dosage form
- Capsule, Extended Release
- Route
- Oral
- Marketing category
- ANDA · ANDA214585
- Marketed since
- May 13, 2022
- Listing expires
- December 31, 2026
- Pharmacologic class
- Aminosalicylate
Active ingredients
- Mesalamine 500 mg/1
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 63304-089-13 | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-089-13) | May 13, 2022 |
Recalls mentioning this NDC
- D-0350-2024 Mar 6, 2024 · Class II
Failed Dissolution Specifications: Out of specification for dissolution.
Other Mesalamine products
- 62332-724 Mesalamine .375 g/1 · Capsule, Extended Release · Alembic Pharmaceuticals Inc.
- 46708-724 Mesalamine .375 g/1 · Capsule, Extended Release · Alembic Pharmaceuticals Limited
- 60687-650 Mesalamine .375 g/1 · Capsule, Extended Release · American Health Packaging
- 67877-717 Mesalamine .375 g/1 · Capsule, Extended Release · Ascend Laboratories, LLC
- 59651-397 Mesalamine .375 g/1 · Capsule, Extended Release · Aurobindo Pharma Limited
- 50268-577 Mesalamine .375 g/1 · Capsule, Extended Release · AvPAK
- 31722-489 Mesalamine 375 mg/1 · Capsule, Extended Release · Camber Pharmaceuticals, Inc.
- 51407-976 Mesalamine .375 g/1 · Capsule, Extended Release · Golden State Medical Supply, Inc.
- 50742-371 Mesalamine .375 g/1 · Capsule, Extended Release · Ingenus Pharmaceuticals, LLC
- 0378-1375 Mesalamine .375 g/1 · Capsule, Extended Release · Mylan Pharmaceuticals Inc.
- 68682-113 Mesalamine 375 mg/1 · Capsule, Extended Release · Oceanside Pharmaceuticals
- 0781-2793 Mesalamine 500 mg/1 · Capsule, Extended Release · Sandoz Inc