Mesalamine
- Product NDC
- 68382-452
- 11-digit product format
- 683820452
- Labeler code
- 68382
- Product ID
- 68382-452_1d3ac6ac-1404-492a-890f-5ed6e250b380
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mesalamine
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA208954
- Marketing category
- ANDA
- Marketing start
- 2021-08-13
- Substance
- MESALAMINE
- Active strength
- .375 g/1
- Pharmacologic classes
- Aminosalicylate [EPC], Aminosalicylic Acids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 4Q81I59GXC | MESALAMINE | 89-57-6 | MESALAMINE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68382-452-19 | 68382045219 | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-452-19) | 2021-08-13 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Mesalamine | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 2023-10-26 | HUMAN PRESCRIPTION DRUG LABEL | 4 |