Mesalamine
- Product NDC
- 63304-089
- 11-digit product format
- 633040089
- Labeler code
- 63304
- Product ID
- 63304-089_d41a599a-71be-4294-9b53-d1cbefe905d5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mesalamine
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries Inc.
- Application
- ANDA214585
- Marketing category
- ANDA
- Marketing start
- 2022-05-13
- Substance
- MESALAMINE
- Active strength
- 500 mg/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 | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4Q81I59GXC |
| Rxcui | 476362 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63304-089-13 | Mesalamine | 120 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 120 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63304-089 | MESALAMINE CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES INC.] | 11 | Current NDC, Legacy NDC, 1 package rows | 20240831_c2f84490-70b8-4998-907d-a77e9f791de1.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 |
|---|
| 63304-089-13 | 63304008913 | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-089-13) | 2022-05-13 | 0000-00-00 | No | No | Current |