Mesalamine
- Product NDC
- 59651-397
- 11-digit product format
- 596510397
- Labeler code
- 59651
- Product ID
- 59651-397_904a1ef1-2677-46f0-bfdb-645d1638d5dc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mesalamine
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA214477
- Marketing category
- ANDA
- Marketing start
- 2023-03-31
- 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 |
|---|
| 59651-397-08 | Mesalamine | 120 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 120 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-397 | MESALAMINE CAPSULE, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED] | 5 | Current NDC, 1 package rows | 20240123_d6c0fc76-644e-4301-9672-f432061e3d37.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 59651-397-08 | 59651039708 | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-397-08) | 2023-03-31 | No | No | Current |