Valsartan
- Product NDC
- 50228-134
- 11-digit product format
- 502280134
- Labeler code
- 50228
- Product ID
- 50228-134_f1da8d58-f8d8-3616-e053-2995a90a27ea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Valsartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- ScieGen Pharmaceuticals, INC.
- Application
- ANDA204038
- Marketing category
- ANDA
- Marketing start
- 2021-10-27
- Substance
- VALSARTAN
- Active strength
- 80 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 | 80 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 |
|---|
| 50228-134-10 | Valsartan | 1000 in 1 BOTTLE | TABLET | 1000 | | 2 |
| 50228-134-30 | Valsartan | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50228-134 | VALSARTAN TABLET [SCIEGEN PHARMACEUTICALS, INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20230110_1a8af3d9-4053-4233-82a7-e8c7bc9e302f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50228-134-10 | 50228013410 | 1000 TABLET in 1 BOTTLE (50228-134-10) | 1000 tablet | 2021-10-27 | 0000-00-00 | No | No | Current |
| 50228-134-30 | 50228013430 | 30 TABLET in 1 BOTTLE (50228-134-30) | 30 tablet | 2021-10-27 | 0000-00-00 | No | No | Current |