Mesalamine
- Product NDC
- 63304-175
- 11-digit product format
- 633040175
- Labeler code
- 63304
- Product ID
- 63304-175_3f29d761-eab5-4f6b-a4f4-ffcc072648e3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mesalamine
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA211858
- Marketing category
- ANDA
- Marketing start
- 2019-02-01
- 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 |
|---|
| 63304-175-13 | Mesalamine | 120 in 1 BOTTLE | TABLET, DELAYED RELEASE | 120 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63304-175 | MESALAMINE TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 16 | Current NDC, Legacy NDC, 1 package rows | 20231202_fd8b02de-7dfa-444d-a1f8-1436b578e0cb.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 |
|---|
| 63304-175-13 | 63304017513 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (63304-175-13) | 2019-02-01 | 0000-00-00 | No | No | Current |