Valsartan and Hydrochlorothiazide
- Product NDC
- 65162-848
- 11-digit product format
- 651620848
- Labeler code
- 65162
- Product ID
- 65162-848_e40f4475-c8d3-48a6-913f-cf7c8c7b119b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Valsartan and Hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA204382
- Marketing category
- ANDA
- Marketing start
- 2023-08-14
- Substance
- HYDROCHLOROTHIAZIDE; VALSARTAN
- Active strength
- 12.5; 320 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
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 |
|---|
| 65162-848-03 | 65162084803 | 30 TABLET, FILM COATED in 1 BOTTLE (65162-848-03) | 2023-08-14 | No | No | Historical |
| 65162-848-09 | 65162084809 | 90 TABLET, FILM COATED in 1 BOTTLE (65162-848-09) | 2023-08-14 | No | No | Historical |
| 65162-848-11 | 65162084811 | 1000 TABLET, FILM COATED in 1 BOTTLE (65162-848-11) | 2023-08-14 | No | No | Historical |
| 65162-848-50 | 65162084850 | 500 TABLET, FILM COATED in 1 BOTTLE (65162-848-50) | 2023-08-14 | No | No | Historical |