Amlodipine, Valsartan and Hydrochlorothiazide
- Product NDC
- 68180-771
- 11-digit product format
- 681800771
- Labeler code
- 68180
- Product ID
- 68180-771_5e938b33-b86d-40ab-b5c5-b7137ef9404d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine, Valsartan and Hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA200797
- Marketing category
- ANDA
- Marketing start
- 2015-06-04
- Substance
- AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
- Active strength
- 5; 12.5; 160 mg/1; mg/1; mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], 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
- Amlodipine, Valsartan and Hydrochlorothiazide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMLODIPINE BESYLATE | 5 mg/1 |
| HYDROCHLOROTHIAZIDE | 12.5 mg/1 |
| VALSARTAN | 160 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 864V2Q084H, 80M03YXJ7I, 0J48LPH2TH |
| Rxcui | 848131, 848135, 848140, 848145, 848151 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68180-771-02 | Amlodipine, Valsartan and Hydrochlorothiazide | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 11 |
| 68180-771-06 | Amlodipine, Valsartan and Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 11 |
| 68180-771-09 | Amlodipine, 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 |
|---|
| AMLODIPINE BESYLATE | ACTIVE INGREDIENT | 864V2Q084H | AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| HYDROCHLOROTHIAZIDE | ACTIVE INGREDIENT | 0J48LPH2TH | AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| VALSARTAN | ACTIVE INGREDIENT | 80M03YXJ7I | AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| AMLODIPINE | ACTIVE MOIETY | 1J444QC288 | AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| HYDROCHLOROTHIAZIDE | ACTIVE MOIETY | 0J48LPH2TH | AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| VALSARTAN | ACTIVE MOIETY | 80M03YXJ7I | AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-771 | AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 11 | Current NDC, Legacy NDC, 3 package rows | 20231215_5dbb43b1-3ea4-4fa5-a9aa-95d869ae65fe.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 |
|---|
| 68180-771-02 | 68180077102 | 500 TABLET, FILM COATED in 1 BOTTLE (68180-771-02) | 2015-06-04 | 0000-00-00 | No | No | Current |
| 68180-771-06 | 68180077106 | 30 TABLET, FILM COATED in 1 BOTTLE (68180-771-06) | 2015-06-04 | 0000-00-00 | No | No | Current |
| 68180-771-09 | 68180077109 | 90 TABLET, FILM COATED in 1 BOTTLE (68180-771-09) | 2015-06-04 | 0000-00-00 | No | No | Current |