Amlodipine and Valsartan
- Product NDC
- 46708-461
- 11-digit product format
- 467080461
- Labeler code
- 46708
- Product ID
- 46708-461_3fb35d37-f05c-44ff-be96-076adaa6da32
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine and Valsartan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA202713
- Marketing category
- ANDA
- Marketing start
- 2016-12-01
- Substance
- AMLODIPINE BESYLATE; VALSARTAN
- Active strength
- 10; 320 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 | 320 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 864V2Q084H, 80M03YXJ7I |
| Rxcui | 722126, 722131, 722134, 722137 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 46708-461-10 | 2023-01-31 | C162847 | 48780-1 | f386c649-b09b-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use AMLODIPINE AND VALSARTAN TABLETS safely and effectively. See full prescribing information for AMLODIPINE AND VALSARTAN TABLETS . AMLODIPINE and VALSARTAN tablets, for oral use. Initial U.S. Approval: 2007 |
| 46708-461-30 | 2023-01-31 | C162847 | 48780-1 | f386c649-b09b-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use AMLODIPINE AND VALSARTAN TABLETS safely and effectively. See full prescribing information for AMLODIPINE AND VALSARTAN TABLETS . AMLODIPINE and VALSARTAN tablets, for oral use. Initial U.S. Approval: 2007 |
| 46708-461-31 | 2023-01-31 | C162847 | 48780-1 | f386c649-b09b-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use AMLODIPINE AND VALSARTAN TABLETS safely and effectively. See full prescribing information for AMLODIPINE AND VALSARTAN TABLETS . AMLODIPINE and VALSARTAN tablets, for oral use. Initial U.S. Approval: 2007 |
| 46708-461-71 | 2023-01-31 | C162847 | 48780-1 | f386c649-b09b-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use AMLODIPINE AND VALSARTAN TABLETS safely and effectively. See full prescribing information for AMLODIPINE AND VALSARTAN TABLETS . AMLODIPINE and VALSARTAN tablets, for oral use. Initial U.S. Approval: 2007 |
| 46708-461-90 | 2023-01-31 | C162847 | 48780-1 | f386c649-b09b-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use AMLODIPINE AND VALSARTAN TABLETS safely and effectively. See full prescribing information for AMLODIPINE AND VALSARTAN TABLETS . AMLODIPINE and VALSARTAN tablets, for oral use. Initial U.S. Approval: 2007 |
| 46708-461-10 | 2023-01-30 | C162847 | 48780-1 | f386c649-b09b-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use AMLODIPINE AND VALSARTAN TABLETS safely and effectively. See full prescribing information for AMLODIPINE AND VALSARTAN TABLETS . AMLODIPINE and VALSARTAN tablets, for oral use. Initial U.S. Approval: 2007 |
| 46708-461-30 | 2023-01-30 | C162847 | 48780-1 | f386c649-b09b-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use AMLODIPINE AND VALSARTAN TABLETS safely and effectively. See full prescribing information for AMLODIPINE AND VALSARTAN TABLETS . AMLODIPINE and VALSARTAN tablets, for oral use. Initial U.S. Approval: 2007 |
| 46708-461-31 | 2023-01-30 | C162847 | 48780-1 | f386c649-b09b-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use AMLODIPINE AND VALSARTAN TABLETS safely and effectively. See full prescribing information for AMLODIPINE AND VALSARTAN TABLETS . AMLODIPINE and VALSARTAN tablets, for oral use. Initial U.S. Approval: 2007 |
| 46708-461-71 | 2023-01-30 | C162847 | 48780-1 | f386c649-b09b-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use AMLODIPINE AND VALSARTAN TABLETS safely and effectively. See full prescribing information for AMLODIPINE AND VALSARTAN TABLETS . AMLODIPINE and VALSARTAN tablets, for oral use. Initial U.S. Approval: 2007 |
| 46708-461-90 | 2023-01-30 | C162847 | 48780-1 | f386c649-b09b-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use AMLODIPINE AND VALSARTAN TABLETS safely and effectively. See full prescribing information for AMLODIPINE AND VALSARTAN TABLETS . AMLODIPINE and VALSARTAN tablets, for oral use. Initial U.S. Approval: 2007 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-461-10 | Amlodipine and Valsartan | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 3 |
| 46708-461-30 | Amlodipine and Valsartan | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 46708-461-31 | Amlodipine and Valsartan | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 3 |
| 46708-461-71 | Amlodipine and Valsartan | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 3 |
| 46708-461-90 | Amlodipine and Valsartan | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-461 | AMLODIPINE AND VALSARTAN TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] | 3 | Current NDC, Legacy NDC, 5 package rows | 20230202_a9c442dc-749e-4de0-bca3-1044eb78da72.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 |
|---|
| 46708-461-10 | 46708046110 | 100 TABLET, FILM COATED in 1 CARTON (46708-461-10) | 2016-12-01 | 0000-00-00 | No | No | Current |
| 46708-461-30 | 46708046130 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-461-30) | 2016-12-01 | 0000-00-00 | No | No | Current |
| 46708-461-31 | 46708046131 | 100 TABLET, FILM COATED in 1 BOTTLE (46708-461-31) | 2016-12-01 | 0000-00-00 | No | No | Current |
| 46708-461-71 | 46708046171 | 500 TABLET, FILM COATED in 1 BOTTLE (46708-461-71) | 2016-12-01 | 0000-00-00 | No | No | Current |
| 46708-461-90 | 46708046190 | 90 TABLET, FILM COATED in 1 BOTTLE (46708-461-90) | 2016-12-01 | 0000-00-00 | No | No | Current |