Mesalamine
- Product NDC
- 0378-7401
- 11-digit product format
- 003787401
- Labeler code
- 0378
- Product ID
- 0378-7401_d7f58b97-5670-46b2-984d-1ced9cf67047
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mesalamine Film Coated
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA203574
- Marketing category
- ANDA
- Marketing start
- 2018-12-14
- Marketing end
- 0000-00-00
- Substance
- MESALAMINE
- Active strength
- 1 g/1
- Pharmacologic classes
- Aminosalicylate [EPC],Aminosalicylic Acids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-7401-78 | 00378740178 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-7401-78) | 2018-12-14 | 0000-00-00 | No | No | Current |