Mesalamine
- Product NDC
- 42291-564
- 11-digit product format
- 422910564
- Labeler code
- 42291
- Product ID
- 42291-564_d57db043-b83e-37b3-e053-2a95a90a9a02
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mesalamine
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA203817
- Marketing category
- ANDA
- Marketing start
- 2019-09-18
- 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
- 2023-12-31
- 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 |
|---|
| 42291-564-12 | 42291056412 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-564-12) | 2019-09-18 | 0000-00-00 | No | No | Current |