Mesalamine
- Product NDC
- 0832-6056
- 11-digit product format
- 008326056
- Labeler code
- 0832
- Product ID
- 0832-6056_44e0cd4f-abe7-5e61-e063-6294a90a988b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mesalamine
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Upsher-Smith Laboratories, LLC
- Application
- ANDA217533
- Marketing category
- ANDA
- Marketing start
- 2023-06-06
- 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 |
|---|
| 0832-6056-12 | 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 |
|---|
| 0832-6056 | MESALAMINE CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, LLC] | 3 | Current NDC, 1 package rows | 20241212_1e6978d0-01db-477d-a90f-27561777480f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0832-6056-12 | 00832605612 | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0832-6056-12) | 2023-07-25 | No | No | Current |