VALSARTAN AND HYDROCHLOROTHIAZIDE
- Product NDC
- 71335-2617
- 11-digit product format
- 713352617
- Labeler code
- 71335
- Product ID
- 71335-2617_89dc73d5-773d-41a1-8fcc-77386ffec68e
- 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; 160 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 table| Ingredient | Strength |
|---|
| HYDROCHLOROTHIAZIDE | 12.5 mg/1 |
| VALSARTAN | 160 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0J48LPH2TH, 80M03YXJ7I |
| Rxcui | 200285 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2617-1 | 71335261701 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2617-1) | 2025-05-29 | No | No | Historical |
| 71335-2617-2 | 71335261702 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2617-2) | 2025-05-29 | No | No | Historical |