Valsartan and Hydrochlorothiazide
- Product NDC
- 62332-080
- 11-digit product format
- 623320080
- Labeler code
- 62332
- Product ID
- 62332-080_29d9e9d2-2c11-49c0-b397-cd429cf701df
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Valsartan and Hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA201662
- Marketing category
- ANDA
- Marketing start
- 2016-05-20
- 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 | 200284, 200285, 349353, 636042, 636045 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62332-080-10 | Valsartan and Hydrochlorothiazide | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 11 |
| 62332-080-30 | Valsartan and Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 11 |
| 62332-080-71 | Valsartan and Hydrochlorothiazide | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 11 |
| 62332-080-90 | Valsartan and Hydrochlorothiazide | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62332-080 | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.] | 11 | Current NDC, Legacy NDC, 4 package rows | 20240622_973973a3-9fec-4afc-910f-187f099dfe2d.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 |
|---|
| 62332-080-10 | 62332008010 | 100 TABLET, FILM COATED in 1 CARTON (62332-080-10) | 2016-05-20 | 0000-00-00 | No | No | Current |
| 62332-080-30 | 62332008030 | 30 TABLET, FILM COATED in 1 BOTTLE (62332-080-30) | 2016-05-20 | 0000-00-00 | No | No | Current |
| 62332-080-71 | 62332008071 | 500 TABLET, FILM COATED in 1 BOTTLE (62332-080-71) | 2016-05-20 | 0000-00-00 | No | No | Current |
| 62332-080-90 | 62332008090 | 90 TABLET, FILM COATED in 1 BOTTLE (62332-080-90) | 2016-05-20 | 0000-00-00 | No | No | Current |