Valsartan
- Product NDC
- 53746-837
- 11-digit product format
- 537460837
- Labeler code
- 53746
- Product ID
- 53746-837_254b9473-bbcb-4780-a182-ba287b886a47
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Valsartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA204011
- Marketing category
- ANDA
- Marketing start
- 2023-08-01
- Substance
- VALSARTAN
- Active strength
- 40 mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Valsartan
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| VALSARTAN | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 80M03YXJ7I |
| Rxcui | 349199, 349200, 349201, 349483 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53746-837-05 | Valsartan | 500 in 1 BOTTLE | TABLET | 500 | | 21 |
| 53746-837-30 | Valsartan | 30 in 1 BOTTLE | TABLET | 30 | | 21 |
| 53746-837-60 | Valsartan | 60 in 1 BOTTLE | TABLET | 60 | | 21 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53746-837 | VALSARTAN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 21 | Current NDC, 3 package rows | 20240420_f13587f8-76cb-49ad-9291-5907249d6b8e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 53746-837-05 | 53746083705 | 500 TABLET in 1 BOTTLE (53746-837-05) | 500 tablet | 2023-08-01 | No | No | Historical |
| 53746-837-30 | 53746083730 | 30 TABLET in 1 BOTTLE (53746-837-30) | 30 tablet | 2023-08-01 | No | No | Historical |
| 53746-837-60 | 53746083760 | 60 TABLET in 1 BOTTLE (53746-837-60) | 60 tablet | 2023-08-01 | No | No | Historical |