Valsartan and Hydrochlorothiazide
- Product NDC
- 65862-550
- 11-digit product format
- 658620550
- Labeler code
- 65862
- Product ID
- 65862-550_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
- 12.5; 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 | 12.5 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 |
|---|
| 65862-550-05 | Valsartan and Hydrochlorothiazide | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 11 |
| 65862-550-90 | Valsartan and Hydrochlorothiazide | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HYDROCHLOROTHIAZIDE | ACTIVE INGREDIENT | 0J48LPH2TH | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 4 | |
| VALSARTAN | ACTIVE INGREDIENT | 80M03YXJ7I | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 4 | |
| HYDROCHLOROTHIAZIDE | ACTIVE MOIETY | 0J48LPH2TH | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 4 | |
| VALSARTAN | ACTIVE MOIETY | 80M03YXJ7I | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 4 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 4 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 4 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 4 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 4 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 4 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 4 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 4 | |
| POLYETHYLENE GLYCOL 4000 | INACTIVE INGREDIENT | 4R4HFI6D95 | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 4 | |
| POLYETHYLENE GLYCOL 8000 | INACTIVE INGREDIENT | Q662QK8M3B | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 4 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 4 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-550 | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 11 | Current NDC, Legacy NDC, 2 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 | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65862-550-05 | 65862055005 | 500 TABLET, FILM COATED in 1 BOTTLE (65862-550-05) | 2013-03-21 | 0000-00-00 | No | No | Current |
| 65862-550-90 | 65862055090 | 90 TABLET, FILM COATED in 1 BOTTLE (65862-550-90) | 2013-03-21 | 0000-00-00 | No | No | Current |