Mesalamine
- Product NDC
- 70771-1625
- 11-digit product format
- 707711625
- Labeler code
- 70771
- Product ID
- 70771-1625_e6ae9f47-11d7-4676-b1ae-0c4f4d1830c6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mesalamine
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- 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 |
|---|
| 70771-1625-7 | Mesalamine | 120 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 120 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70771-1625 | MESALAMINE CAPSULE, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED] | 3 | Current NDC, Legacy NDC, 1 package rows | 20241204_04073681-a834-4f45-91c5-224b608b30e6.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 |
|---|
| 70771-1625-7 | 70771162507 | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1625-7) | 2021-08-13 | 0000-00-00 | No | No | Current |