mesalamine
- Product NDC
- 70748-214
- 11-digit product format
- 707480214
- Labeler code
- 70748
- Product ID
- 70748-214_df59b373-25c0-4eb6-a475-44a99a9b9101
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mesalamine
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- NDA022301
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2020-05-18
- Marketing end
- 0000-00-00
- Substance
- MESALAMINE
- Active strength
- 375 mg/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
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70748-214 | MESALAMINE CAPSULE, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 8 | Legacy NDC | 20240112_a69ce2b9-2866-406d-a365-5b185a269e3e.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70748-214-16 | 70748021416 | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70748-214-16) | 2020-05-18 | 0000-00-00 | No | No | Current |