Mesalamine
- Product NDC
- 68382-452
- 11-digit product format
- 683820452
- Labeler code
- 68382
- Product ID
- 68382-452_1d3ac6ac-1404-492a-890f-5ed6e250b380
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mesalamine
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA208954
- Marketing category
- ANDA
- Marketing start
- 2021-08-13
- 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 |
|---|
| 68382-452-19 | Mesalamine | 120 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 120 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-452 | MESALAMINE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20231031_cd8493f7-91fd-4c2d-b3d7-c1301825586b.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 |
|---|
| 68382-452-19 | 68382045219 | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-452-19) | 2021-08-13 | 0000-00-00 | No | No | Current |