Mesalamine
- Product NDC
- 70954-301
- 11-digit product format
- 709540301
- Labeler code
- 70954
- Product ID
- 70954-301_9411a710-a60c-4f4b-a28c-1f72d80eaf35
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mesalamine
- Dosage form
- SUSPENSION
- Route
- RECTAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA215269
- Marketing category
- ANDA
- Marketing start
- 2026-05-14
- Substance
- MESALAMINE
- Active strength
- 4 g/60mL
- Pharmacologic classes
- Aminosalicylate [EPC], Aminosalicylic Acids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Mesalamine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MESALAMINE | 4 g/60mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4Q81I59GXC |
| Rxcui | 238151 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70954-301-10 | Mesalamine | 60 mL in 1 BOTTLE | SUSPENSION | 60 | | 3 |
| 70954-301-20 | Mesalamine | 7 in 1 CARTON | SUSPENSION | 7 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70954-301-10 | 70954030110 | 60 mL in 1 BOTTLE | 60 ml | | | | Historical |
| 70954-301-20 | 70954030120 | 7 BOTTLE in 1 CARTON (70954-301-20) / 60 mL in 1 BOTTLE (70954-301-10) | 7 bottle | 2026-05-14 | No | No | Current |