Valsartan
- Product NDC
- 0378-5813
- 11-digit product format
- 003785813
- Labeler code
- 0378
- Product ID
- 0378-5813_a5384d58-48c7-494a-a8a8-c296b316bd91
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- valsartan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA090866
- Marketing category
- ANDA
- Marketing start
- 2015-01-05
- 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 |
|---|
| 0378-5813-77 | Valsartan | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-5813 | VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 15 | Current NDC, Legacy NDC, 1 package rows | 20240901_73e01dc6-7dd4-421a-a4f6-137e75f69f9a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-5813-77 | 00378581377 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5813-77) | 2015-01-05 | 0000-00-00 | No | No | Current |