Amlodipine and Valsartan
- Product NDC
- 68180-765
- 11-digit product format
- 681800765
- Labeler code
- 68180
- Product ID
- 68180-765_e0777a79-35ef-4f69-b6ac-94d31f7ca6fb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine and Valsartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA090245
- Marketing category
- ANDA
- Marketing start
- 2015-03-31
- Substance
- AMLODIPINE BESYLATE; VALSARTAN
- Active strength
- 10; 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 | 10 mg/1 |
| VALSARTAN | 160 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 80M03YXJ7I, 864V2Q084H |
| 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 |
|---|
| 68180-765-02 | Amlodipine and Valsartan | 500 in 1 BOTTLE | TABLET | 500 | | 14 |
| 68180-765-06 | Amlodipine and Valsartan | 30 in 1 BOTTLE | TABLET | 30 | | 14 |
| 68180-765-09 | Amlodipine and Valsartan | 90 in 1 BOTTLE | TABLET | 90 | | 14 |
| 68180-765-11 | Amlodipine and Valsartan | 10 in 1 BLISTER PACK | TABLET | 10 | | 14 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-765 | AMLODIPINE AND VALSARTAN TABLET [LUPIN PHARMACEUTICALS, INC.] | 14 | Current NDC, Legacy NDC, 4 package rows | 20231215_35086164-bf92-4b3c-9845-f8cd7464c7d6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68180-765-02 | 68180076502 | 500 TABLET in 1 BOTTLE (68180-765-02) | 500 tablet | 2015-03-31 | 0000-00-00 | No | No | Current |
| 68180-765-06 | 68180076506 | 30 TABLET in 1 BOTTLE (68180-765-06) | 30 tablet | 2015-03-31 | 0000-00-00 | No | No | Current |
| 68180-765-09 | 68180076509 | 90 TABLET in 1 BOTTLE (68180-765-09) | 90 tablet | 2015-03-31 | 0000-00-00 | No | No | Current |
| 68180-765-11 | 68180076511 | 10 TABLET in 1 BLISTER PACK (68180-765-11) | 10 tablet | 2015-03-31 | 0000-00-00 | No | No | Current |