AMLODIPINE AND VALSARTAN
- Product NDC
- 0378-1721
- 11-digit product format
- 003781721
- Labeler code
- 0378
- Product ID
- 0378-1721_97bfe7c1-7e4b-45a1-b045-ff48275f1488
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMLODIPINE AND VALSARTAN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA090483
- Marketing category
- ANDA
- Marketing start
- 2015-03-30
- Substance
- AMLODIPINE BESYLATE; VALSARTAN
- Active strength
- 5; 160 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]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- AMLODIPINE AND VALSARTAN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMLODIPINE BESYLATE | 5 mg/1 |
| VALSARTAN | 160 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 864V2Q084H, 80M03YXJ7I |
| Rxcui | 722126, 722131, 722134, 722137 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-1721-93 | AMLODIPINE AND VALSARTAN | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AMLODIPINE BESYLATE | ACTIVE INGREDIENT | 864V2Q084H | AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 1 | |
| VALSARTAN | ACTIVE INGREDIENT | 80M03YXJ7I | AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 1 | |
| AMLODIPINE | ACTIVE MOIETY | 1J444QC288 | AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 1 | |
| VALSARTAN | ACTIVE MOIETY | 80M03YXJ7I | AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE B POTATO | INACTIVE INGREDIENT | 27NA468985 | AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-1721 | AMLODIPINE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 6 | Current NDC, Legacy NDC, 1 package rows | 20240712_aa7e7d95-520a-461c-b1b3-e588aeb6a613.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 |
|---|
| 0378-1721-93 | 00378172193 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1721-93) | 2015-03-30 | 0000-00-00 | No | No | Current |