Valsartan and Hydrochlorothiazide
- Product NDC
- 71335-0853
- 11-digit product format
- 713350853
- Labeler code
- 71335
- Product ID
- 71335-0853_b6e7eaa2-5cdb-4d2a-8452-e102792cf665
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Valsartan and Hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA201662
- Marketing category
- ANDA
- Marketing start
- 2016-05-20
- Substance
- HYDROCHLOROTHIAZIDE; VALSARTAN
- Active strength
- 25; 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
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 | 320 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0J48LPH2TH, 80M03YXJ7I |
| Rxcui | 636045 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-0853-1 | Valsartan and Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
| 71335-0853-2 | Valsartan and Hydrochlorothiazide | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-0853 | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240724_d57188d2-c3af-4879-bf17-f37eaf733aca.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 |
|---|
| 71335-0853-1 | 71335085301 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-0853-1) | 2018-06-11 | 0000-00-00 | No | No | Current |
| 71335-0853-2 | 71335085302 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-0853-2) | 2024-07-09 | 0000-00-00 | No | No | Current |