MESALAMINE
- Product NDC
- 72162-2213
- 11-digit product format
- 721622213
- Labeler code
- 72162
- Product ID
- 72162-2213_ca8d9aee-7467-4c57-8676-69293b81d7e0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mesalamine
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA217337
- Marketing category
- ANDA
- Marketing start
- 2023-06-03
- Substance
- MESALAMINE
- Active strength
- 1.2 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 |
|---|
| 72162-2213-2 | 72162221302 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (72162-2213-2) | 2024-05-29 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| MESALAMINE | Bryant Ranch Prepack | 2024-05-29 | HUMAN PRESCRIPTION DRUG LABEL | 101 |