MESALAMINE
- Product NDC
- 84725-002
- 11-digit product format
- 847250002
- Labeler code
- 84725
- Product ID
- 84725-002_8a38e94f-51e1-4ce1-89a4-437f7d4d5664
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mesalamine
- Dosage form
- SUSPENSION
- Route
- RECTAL
- Labeler
- KLM Laboratories Private Limited
- Application
- ANDA220016
- Marketing category
- ANDA
- Marketing start
- 2026-04-01
- 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 |
|---|
| 84725-002-03 | MESALAMINE | 7 in 1 CARTON | SUSPENSION | 7 | | 5 |
| 84725-002-03 | MESALAMINE | 60 mL in 1 BOTTLE | SUSPENSION | 60 | | 5 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 84725-002-03 | 84725000203 | 7 BOTTLE in 1 CARTON (84725-002-03) / 60 mL in 1 BOTTLE | 7 bottle | 2026-04-01 | No | No | Current |