mesalamine
- Product NDC
- 68382-435
- 11-digit product format
- 683820435
- Labeler code
- 68382
- Product ID
- 68382-435_c2b40002-6c58-4c89-b178-c915a59cb2dd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mesalamine
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA203286
- Marketing category
- ANDA
- Marketing start
- 2018-08-02
- Substance
- MESALAMINE
- Active strength
- 800 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 | 800 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4Q81I59GXC |
| Rxcui | 833234 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68382-435-28 | mesalamine | 180 in 1 BOTTLE | TABLET, DELAYED RELEASE | 180 | | 8 |
| 68382-435-30 | mesalamine | 10 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 10 | | 8 |
| 68382-435-77 | mesalamine | 10 in 1 CARTON | TABLET, DELAYED RELEASE | 10 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-435 | MESALAMINE TABLET, DELAYED RELEASE [ZYDUS PHARMACEUTICALS USA INC.] | 8 | Current NDC, Legacy NDC, 3 package rows | 20230812_ad8c7930-92e2-4372-a874-da22b9ae333e.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 |
|---|
| 68382-435-28 | 68382043528 | 180 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-435-28) | | 2018-08-02 | 0000-00-00 | No | No | Current |
| 68382-435-30 | 68382043530 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 68382-435-77 | 68382043577 | 10 BLISTER PACK in 1 CARTON (68382-435-77) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (68382-435-30) | 10 blister pack | 2018-08-02 | 0000-00-00 | No | No | Current |