Amlodipine and Valsartan is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Alembic Pharmaceuticals Inc.. The primary component is Amlodipine Besylate; Valsartan.
| Product ID | 62332-205_17f06055-d323-44d0-ab61-54e407e17763 |
| NDC | 62332-205 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Amlodipine and Valsartan |
| Generic Name | Amlodipine And Valsartan |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2016-12-01 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA202713 |
| Labeler Name | Alembic Pharmaceuticals Inc. |
| Substance Name | AMLODIPINE BESYLATE; VALSARTAN |
| Active Ingredient Strength | 5 mg/1; mg/1 |
| Pharm 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 | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2016-12-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA202713 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2016-12-01 |
| Marketing Category | ANDA |
| Application Number | ANDA202713 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2016-12-01 |
| Marketing Category | ANDA |
| Application Number | ANDA202713 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2016-12-01 |
| Marketing Category | ANDA |
| Application Number | ANDA202713 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2016-12-01 |
| Marketing Category | ANDA |
| Application Number | ANDA202713 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2016-12-01 |
| Ingredient | Strength |
|---|---|
| AMLODIPINE BESYLATE | 5 mg/1 |
| SPL SET ID: | 6894085d-6076-4e2e-8105-a9bbb0bd93ef |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0093-7690 | Amlodipine and Valsartan | Amlodipine and Valsartan |
| 0093-7692 | Amlodipine and Valsartan | Amlodipine and Valsartan |
| 0093-7693 | Amlodipine and Valsartan | Amlodipine and Valsartan |
| 0378-1721 | AMLODIPINE AND VALSARTAN | AMLODIPINE AND VALSARTAN |
| 0378-1722 | AMLODIPINE AND VALSARTAN | AMLODIPINE AND VALSARTAN |
| 0378-1723 | AMLODIPINE AND VALSARTAN | AMLODIPINE AND VALSARTAN |
| 0378-1724 | AMLODIPINE AND VALSARTAN | AMLODIPINE AND VALSARTAN |
| 0781-5615 | AMLODIPINE AND VALSARTAN | amlodipine besylate and valsartan |
| 0781-5628 | AMLODIPINE AND VALSARTAN | amlodipine besylate and valsartan |
| 0781-5639 | AMLODIPINE AND VALSARTAN | amlodipine besylate and valsartan |
| 0781-5643 | AMLODIPINE AND VALSARTAN | amlodipine besylate and valsartan |
| 13668-204 | Amlodipine and Valsartan | Amlodipine and Valsartan |
| 13668-205 | Amlodipine and Valsartan | Amlodipine and Valsartan |
| 13668-206 | Amlodipine and Valsartan | Amlodipine and Valsartan |
| 13668-207 | Amlodipine and Valsartan | Amlodipine and Valsartan |
| 40032-080 | Amlodipine and Valsartan | Amlodipine and Valsartan |
| 40032-081 | Amlodipine and Valsartan | Amlodipine and Valsartan |
| 40032-082 | Amlodipine and Valsartan | Amlodipine and Valsartan |
| 40032-083 | AMLODIPINE and VALSARTAN | AMLODIPINE and VALSARTAN |
| 42291-020 | Amlodipine and Valsartan | amlodipine and valsartan |
| 42291-021 | Amlodipine and Valsartan | amlodipine and valsartan |
| 42291-022 | Amlodipine and Valsartan | amlodipine and valsartan |
| 42291-023 | Amlodipine and Valsartan | amlodipine and valsartan |
| 43386-080 | Amlodipine and Valsartan | Amlodipine and Valsartan |
| 43386-081 | Amlodipine and Valsartan | Amlodipine and Valsartan |
| 43386-082 | Amlodipine and Valsartan | Amlodipine and Valsartan |
| 43386-083 | AMLODIPINE and VALSARTAN | AMLODIPINE and VALSARTAN |
| 45865-880 | Amlodipine and Valsartan | Amlodipine and Valsartan |
| 45865-882 | Amlodipine and Valsartan | Amlodipine and Valsartan |
| 45865-889 | Amlodipine and Valsartan | Amlodipine and Valsartan |
| 68180-765 | Amlodipine and Valsartan | Amlodipine and Valsartan |
| 68180-767 | Amlodipine and Valsartan | Amlodipine and Valsartan |
| 68180-764 | Amlodipine and Valsartan | Amlodipine and Valsartan |
| 68180-766 | Amlodipine and Valsartan | Amlodipine and Valsartan |
| 46708-460 | Amlodipine and Valsartan | Amlodipine and Valsartan |
| 45865-890 | Amlodipine and valsartan | Amlodipine and valsartan |
| 46708-461 | Amlodipine and Valsartan | Amlodipine and Valsartan |
| 46708-458 | Amlodipine and Valsartan | Amlodipine and Valsartan |
| 46708-459 | Amlodipine and Valsartan | Amlodipine and Valsartan |
| 49884-574 | Amlodipine and Valsartan | Amlodipine and Valsartan |
| 49884-576 | Amlodipine and Valsartan | Amlodipine and Valsartan |
| 49884-575 | Amlodipine and Valsartan | Amlodipine and Valsartan |
| 49884-577 | Amlodipine and Valsartan | Amlodipine and Valsartan |
| 50090-2471 | AMLODIPINE AND VALSARTAN | AMLODIPINE AND VALSARTAN |
| 57297-766 | Amlodipine and Valsartan | Amlodipine and Valsartan |
| 57297-767 | Amlodipine and Valsartan | Amlodipine and Valsartan |
| 57297-765 | Amlodipine and Valsartan | Amlodipine and Valsartan |
| 57297-764 | Amlodipine and Valsartan | Amlodipine and Valsartan |
| 62332-206 | Amlodipine and Valsartan | Amlodipine and Valsartan |
| 62332-208 | Amlodipine and Valsartan | Amlodipine and Valsartan |