Valsartan and Hydrochlorothiazide
- Product NDC
- 63187-312
- 11-digit product format
- 631870312
- Labeler code
- 63187
- Product ID
- 63187-312_9773ffda-a126-4f03-868f-ca5e0d71feee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Valsartan and Hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA202519
- Marketing category
- ANDA
- Marketing start
- 2013-03-21
- 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
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 |
|---|
| 63187-312-30 | 63187031230 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-312-30) | 2018-12-01 | No | No | Historical |
| 63187-312-90 | 63187031290 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-312-90) | 2019-01-01 | No | No | Historical |