mesalamine
- Product NDC
- 0904-6832
- 11-digit product format
- 009046832
- Labeler code
- 0904
- Product ID
- 0904-6832_cf19237e-af40-4db5-96e6-c53e6a6d4b59
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mesalamine
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA091640
- Marketing category
- ANDA
- Marketing start
- 2017-06-19
- 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 |
|---|
| 0904-6832-04 | mesalamine | 1 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 1 | | 7 |
| 0904-6832-04 | mesalamine | 30 in 1 CARTON | TABLET, DELAYED RELEASE | 30 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-6832 | MESALAMINE TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241122_14ac4435-903b-41f5-a3c4-8c73de3e4cef.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0904-6832-04 | 00904683204 | 30 BLISTER PACK in 1 CARTON (0904-6832-04) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK | 30 blister pack | 2017-06-19 | 0000-00-00 | No | No | Current |