Mesalamine
- Product NDC
- 0378-9230
- 11-digit product format
- 003789230
- Labeler code
- 0378
- Product ID
- 0378-9230_9fd90178-4259-4d79-9339-384352f188c3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mesalamine
- Dosage form
- SUPPOSITORY
- Route
- RECTAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA204354
- Marketing category
- ANDA
- Marketing start
- 2018-12-17
- Marketing end
- 2023-03-31
- Substance
- MESALAMINE
- Active strength
- 1000 mg/1
- Pharmacologic classes
- Aminosalicylate [EPC], Aminosalicylic Acids [CS]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-9230-93 | 00378923093 | 5 PACKAGE in 1 CARTON (0378-9230-93) > 6 SUPPOSITORY in 1 PACKAGE | 5 package | 2018-12-17 | 0000-00-00 | No | No | Current |