Valsartan and Hydrochlorothiazide
- Product NDC
- 0378-6325
- 11-digit product format
- 003786325
- Labeler code
- 0378
- Product ID
- 0378-6325_16044239-373d-4b04-9a4d-fd4232a93b6c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- valsartan and hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA078020
- Marketing category
- ANDA
- Marketing start
- 2012-09-21
- 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 |
|---|
| 0378-6325-05 | Valsartan and Hydrochlorothiazide | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 500 | | 20 |
| 0378-6325-77 | Valsartan and Hydrochlorothiazide | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 20 |
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 [MYLAN PHARMACEUTICALS INC.] | 9 | |
| VALSARTAN | ACTIVE INGREDIENT | 80M03YXJ7I | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 9 | |
| HYDROCHLOROTHIAZIDE | ACTIVE MOIETY | 0J48LPH2TH | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 9 | |
| VALSARTAN | ACTIVE MOIETY | 80M03YXJ7I | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 9 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 9 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 9 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 9 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 9 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 9 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 9 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 9 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 9 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 9 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 9 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 9 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 9 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 9 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 9 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 9 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 9 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 9 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-6325 | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 20 | Current NDC, Legacy NDC, 2 package rows | 20240508_3ba1f9f9-0037-4522-8605-e27dc8552b5b.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 |
|---|
| 0378-6325-05 | 00378632505 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6325-05) | 2012-09-21 | 2021-07-31 | No | No | Current |
| 0378-6325-77 | 00378632577 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6325-77) | 2012-09-21 | 0000-00-00 | No | No | Current |