Valsartan and Hydrochlorothiazide
- Product NDC
- 53746-847
- 11-digit product format
- 537460847
- Labeler code
- 53746
- Product ID
- 53746-847_1ed15f09-2051-401f-a320-5f04b85ac8e2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Valsartan and Hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA204382
- Marketing category
- ANDA
- Marketing start
- 2023-08-14
- Substance
- HYDROCHLOROTHIAZIDE; VALSARTAN
- Active strength
- 25; 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 | 25 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 |
|---|
| 53746-847-90 | Valsartan and Hydrochlorothiazide | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53746-847 | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 4 | Current NDC, 1 package rows | 20230815_d5a1db33-3046-407c-a557-6b41642164a9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 53746-847-90 | 53746084790 | 90 TABLET, FILM COATED in 1 BOTTLE (53746-847-90) | 2023-08-14 | No | No | Historical |