Mesalamine
- Product NDC
- 0378-1375
- 11-digit product format
- 003781375
- Labeler code
- 0378
- Product ID
- 0378-1375_74ab5fdd-ccdd-403d-af79-fd34a1cc939f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mesalamine
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA207271
- Marketing category
- ANDA
- Marketing start
- 2019-11-26
- Substance
- MESALAMINE
- Active strength
- .375 g/1
- Pharmacologic classes
- Aminosalicylate [EPC], Aminosalicylic Acids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Mesalamine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MESALAMINE | .375 g/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4Q81I59GXC |
| Rxcui | 825130 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-1375-78 | Mesalamine | 120 in 1 BOTTLE, PLASTIC | CAPSULE, EXTENDED RELEASE | 120 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-1375 | MESALAMINE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20231223_c8b93ea3-0367-4605-b87f-06c3812ff3b7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-1375-78 | 00378137578 | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1375-78) | 2019-11-26 | 0000-00-00 | No | No | Current |