MESALAMINE
- Product NDC
- 31722-489
- 11-digit product format
- 317220489
- Labeler code
- 31722
- Product ID
- 31722-489_4597df51-7ed6-14f4-e063-6294a90afb23
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MESALAMINE
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA219864
- Marketing category
- ANDA
- Marketing start
- 2025-08-13
- 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 |
|---|
| 31722-489-12 | MESALAMINE | 120 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 120 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 31722-489-12 | 31722048912 | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-489-12) | 2025-08-13 | No | No | Historical |