mesalamine
- Product NDC
- 0093-9224
- 11-digit product format
- 000939224
- Labeler code
- 0093
- Product ID
- 0093-9224_0ce3f59e-e447-81a0-e063-6394a90ab0c3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mesalamine
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- NDA022301
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2021-01-05
- Substance
- MESALAMINE
- Active strength
- 375 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 | 375 mg/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 |
|---|
| 0093-9224-89 | mesalamine | 120 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 120 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-9224 | MESALAMINE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA, INC.] | 8 | Current NDC, Legacy NDC, 1 package rows | 20231220_8d27a608-3ba1-4799-be38-c00fb08ce3ce.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 |
|---|
| 0093-9224-89 | 00093922489 | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-9224-89) | 2021-01-05 | 0000-00-00 | No | No | Current |