Mesalamine
- Product NDC
- 65162-360
- 11-digit product format
- 651620360
- Labeler code
- 65162
- Product ID
- 65162-360_21f01ad5-99ad-49d4-b3d6-2b9470238f22
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mesalamine
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA215067
- Marketing category
- ANDA
- Marketing start
- 2025-02-19
- Substance
- MESALAMINE
- Active strength
- 800 mg/1
- 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 | 800 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4Q81I59GXC |
| Rxcui | 833234 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65162-360-18 | Mesalamine | 180 in 1 BOTTLE | TABLET, DELAYED RELEASE | 180 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-360 | MESALAMINE TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS LLC] | 9 | Current NDC, 1 package rows | 20250221_00f77203-3615-47e8-ae25-6e1cf8a2a00a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 65162-360-18 | 65162036018 | 180 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-360-18) | 2025-02-19 | No | No | Current |