VALSARTAN AND HYDROCHLOROTHIAZIDE
- Product NDC
- 71335-2618
- 11-digit product format
- 713352618
- Labeler code
- 71335
- Product ID
- 71335-2618_d8337422-aaf5-4a1d-9b3c-4e4dbd34db59
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- valsartan and hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA206083
- Marketing category
- ANDA
- Marketing start
- 2015-10-31
- Substance
- HYDROCHLOROTHIAZIDE; VALSARTAN
- Active strength
- 12.5; 80 mg/1; mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data
- Finished product
- Yes
- Brand name base
- VALSARTAN AND HYDROCHLOROTHIAZIDE
- Listing expiration
- 2026-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| HYDROCHLOROTHIAZIDE | 12.5 mg/1 |
| VALSARTAN | 80 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | 0J48LPH2TH, 80M03YXJ7I |
| Rxcui | 200284 |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 0J48LPH2TH | HYDROCHLOROTHIAZIDE | 58-93-5 | HYDROCHLOROTHIAZIDE |
| 80M03YXJ7I | VALSARTAN | 137862-53-4 | VALSARTAN |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2618-1 | 71335261801 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2618-1) | 2025-05-29 | No | No | Historical |
| 71335-2618-2 | 71335261802 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2618-2) | 2025-05-29 | No | No | Historical |