Valsartan and Hydrochlorothiazide
- Product NDC
- 68180-101
- 11-digit product format
- 681800101
- Labeler code
- 68180
- Product ID
- 68180-101_537df828-cd82-4b5e-9d0d-da8bd1cfd736
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Valsartan and Hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA078946
- 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 |
|---|
| 68180-101-02 | Valsartan and Hydrochlorothiazide | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 12 |
| 68180-101-09 | Valsartan and Hydrochlorothiazide | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 12 |
| 68180-101-11 | Valsartan and Hydrochlorothiazide | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 12 |
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 [LUPIN PHARMACEUTICALS, INC.] | 7 | |
| VALSARTAN | ACTIVE INGREDIENT | 80M03YXJ7I | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 7 | |
| HYDROCHLOROTHIAZIDE | ACTIVE MOIETY | 0J48LPH2TH | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 7 | |
| VALSARTAN | ACTIVE MOIETY | 80M03YXJ7I | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 7 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 7 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 7 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 7 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 7 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 7 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 7 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 7 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 7 | |
| STARCH, PREGELATINIZED CORN | INACTIVE INGREDIENT | O8232NY3SJ | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-101 | VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 12 | Current NDC, Legacy NDC, 3 package rows | 20231108_d74a85de-5917-401a-b92d-6a95da5d30a6.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 |
|---|
| 68180-101-02 | 68180010102 | 500 TABLET, FILM COATED in 1 BOTTLE (68180-101-02) | 2013-03-21 | 0000-00-00 | No | No | Current |
| 68180-101-09 | 68180010109 | 90 TABLET, FILM COATED in 1 BOTTLE (68180-101-09) | 2013-03-21 | 0000-00-00 | No | No | Current |
| 68180-101-11 | 68180010111 | 10 TABLET, FILM COATED in 1 BLISTER PACK (68180-101-11) | 2013-03-21 | 0000-00-00 | No | No | Current |