valsartan and hydrochlorothiazide
- Product NDC
- 70771-1489
- 11-digit product format
- 707711489
- Labeler code
- 70771
- Product ID
- 70771-1489_be4934db-c496-4b06-84c6-587cb656d5fc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- valsartan and hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA203000
- Marketing category
- ANDA
- Marketing start
- 2020-02-12
- 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 | 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 |
|---|
| 70771-1489-0 | valsartan and hydrochlorothiazide | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 4 |
| 70771-1489-4 | valsartan and hydrochlorothiazide | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 4 |
| 70771-1489-4 | valsartan and hydrochlorothiazide | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 4 |
| 70771-1489-9 | 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 |
|---|
| 70771-1489 | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] | 4 | Current NDC, Legacy NDC, 4 package rows | 20221109_bd199010-1d85-4011-939c-4704ecfaba1f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70771-1489-0 | 70771148900 | 1000 TABLET, FILM COATED in 1 BOTTLE (70771-1489-0) | | 2020-02-12 | 0000-00-00 | No | No | Current |
| 70771-1489-4 | 70771148904 | 10 BLISTER PACK in 1 CARTON (70771-1489-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2020-02-12 | 0000-00-00 | No | No | Current |
| 70771-1489-9 | 70771148909 | 90 TABLET, FILM COATED in 1 BOTTLE (70771-1489-9) | | 2020-02-12 | 0000-00-00 | No | No | Current |