MESALAMINE
- Product NDC
- 46708-724
- 11-digit product format
- 467080724
- Labeler code
- 46708
- Product ID
- 46708-724_4ef59b85-e5a5-479f-a1fe-e1cee4d87670
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MESALAMINE
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA216967
- Marketing category
- ANDA
- Marketing start
- 2022-11-03
- Substance
- MESALAMINE
- Active strength
- .375 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 | .375 g/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 |
|---|
| 46708-724-35 | MESALAMINE | 120 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 120 | | 1 |
| 46708-724-91 | MESALAMINE | 1000 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 1000 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-724 | MESALAMINE CAPSULE, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | Current NDC, Legacy NDC, 2 package rows | 20221223_4ef59b85-e5a5-479f-a1fe-e1cee4d87670.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 |
|---|
| 46708-724-35 | 46708072435 | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-724-35) | 2022-11-03 | 0000-00-00 | No | No | Current |
| 46708-724-91 | 46708072491 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-724-91) | 2022-11-03 | 0000-00-00 | No | No | Current |