Mesalamine
- Product NDC
- 50742-371
- 11-digit product format
- 507420371
- Labeler code
- 50742
- Product ID
- 50742-371_a250353b-8338-43bf-b451-a0e715293196
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mesalamine
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Ingenus Pharmaceuticals, LLC
- Application
- ANDA218410
- Marketing category
- ANDA
- Marketing start
- 2024-09-23
- 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 |
|---|
| 50742-371-12 | Mesalamine | 120 in 1 BOTTLE, PLASTIC | CAPSULE, EXTENDED RELEASE | 120 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50742-371 | MESALAMINE CAPSULE, EXTENDED RELEASE [INGENUS PHARMACEUTICALS, LLC] | 1 | Current NDC, 1 package rows | 20240924_58503afe-b8d4-4710-a194-e3acd64ecf1f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50742-371-12 | 50742037112 | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50742-371-12) | 2024-09-23 | No | No | Historical |