mesalamine
- Product NDC
- 70771-1071
- 11-digit product format
- 707711071
- Labeler code
- 70771
- Product ID
- 70771-1071_26f195e7-e73a-48e7-b3b0-49f7cbed510a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mesalamine
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA091640
- Marketing category
- ANDA
- Marketing start
- 2017-06-19
- Substance
- MESALAMINE
- Active strength
- 1.2 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 | 1.2 g/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4Q81I59GXC |
| Rxcui | 686429 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70771-1071-1 | mesalamine | 120 in 1 BOTTLE | TABLET, DELAYED RELEASE | 120 | | 7 |
| 70771-1071-2 | mesalamine | 34 in 1 BOTTLE | TABLET, DELAYED RELEASE | 34 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70771-1071 | MESALAMINE TABLET, DELAYED RELEASE [ZYDUS LIFESCIENCES LIMITED] | 7 | Current NDC, Legacy NDC, 2 package rows | 20241204_29c0dd58-d2cf-40fa-bc32-0eab61937331.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 |
|---|
| 70771-1071-1 | 70771107101 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (70771-1071-1) | 2017-06-19 | 0000-00-00 | No | No | Current |
| 70771-1071-2 | 70771107102 | 34 TABLET, DELAYED RELEASE in 1 BOTTLE (70771-1071-2) | 2017-06-19 | 0000-00-00 | No | No | Current |