Valsartan and Hydrochlorothiazide
- Product NDC
- 65862-549
- 11-digit product format
- 658620549
- Labeler code
- 65862
- Product ID
- 65862-549_81a03db7-4be2-478d-b625-e59c8bd2235f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Valsartan and Hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA202519
- Marketing category
- ANDA
- Marketing start
- 2013-03-21
- 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 | 80M03YXJ7I, 0J48LPH2TH |
| 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 |
|---|
| 65862-549-10 | Valsartan and Hydrochlorothiazide | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 11 |
| 65862-549-10 | Valsartan and Hydrochlorothiazide | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 11 |
| 65862-549-90 | Valsartan and Hydrochlorothiazide | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 11 |
| 65862-549-99 | Valsartan and Hydrochlorothiazide | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-549 | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 11 | Current NDC, Legacy NDC, 4 package rows | 20240618_c5bc7c55-b50c-4e61-ad1f-5ebb607c262f.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 |
|---|
| 65862-549-10 | 65862054910 | 10 BLISTER PACK in 1 CARTON (65862-549-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2013-03-21 | 0000-00-00 | No | No | Current |
| 65862-549-26 | 65862054926 | 2500 TABLET, FILM COATED in 1 BAG (65862-549-26) | | 21-MAR-13 | | | | Current |
| 65862-549-90 | 65862054990 | 90 TABLET, FILM COATED in 1 BOTTLE (65862-549-90) | | 2013-03-21 | 0000-00-00 | No | No | Current |
| 65862-549-99 | 65862054999 | 1000 TABLET, FILM COATED in 1 BOTTLE (65862-549-99) | | 2013-03-21 | 0000-00-00 | No | No | Current |