Mesalamine
- Product NDC
- 0480-7750
- 11-digit product format
- 004807750
- Labeler code
- 0480
- Product ID
- 0480-7750_dcee5545-97f3-4418-87f6-5060e540342d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mesalamine
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals, Inc.
- Application
- ANDA213191
- Marketing category
- ANDA
- Marketing start
- 2024-08-22
- Substance
- MESALAMINE
- Active strength
- 800 mg/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 |
|---|
| 0480-7750-80 | 00480775080 | 180 TABLET, DELAYED RELEASE in 1 BOTTLE (0480-7750-80) | 2024-08-22 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Mesalamine | AvKARE | 2026-01-14 | HUMAN PRESCRIPTION DRUG LABEL | 2 |
| Mesalamine | Teva Pharmaceuticals, Inc. | 2024-06-28 | HUMAN PRESCRIPTION DRUG LABEL | 1 |