AMLODIPINE BESYLATE 10 mg is a Oral; Oral; Oral; Oral; Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Vivimed Labs Limited. The primary component is Amlodipine Besylate.
| Product ID | 62980-508_47f12917-32b3-4c67-95eb-29568f509556 |
| NDC | 62980-508 |
| Product Type | Human Prescription Drug |
| Proprietary Name | AMLODIPINE BESYLATE 10 mg |
| Generic Name | Amlodipine Besylate |
| Dosage Form | Tablet |
| Route of Administration | ORAL; ORAL; ORAL; ORAL; ORAL |
| Marketing Start Date | 2015-04-01 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA077516 |
| Labeler Name | Vivimed Labs Limited |
| Substance Name | AMLODIPINE BESYLATE |
| Active Ingredient Strength | 10 mg/1 |
| Pharm Classes | Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2015-04-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA077516 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2015-04-01 |
| Marketing End Date | 2019-11-26 |
| Marketing Category | ANDA |
| Application Number | ANDA077516 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2015-04-01 |
| Marketing End Date | 2019-11-26 |
| Marketing Category | ANDA |
| Application Number | ANDA077516 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-08-12 |
| Marketing End Date | 2019-11-26 |
| Marketing Category | ANDA |
| Application Number | ANDA077516 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-08-12 |
| Marketing End Date | 2019-11-26 |
| Ingredient | Strength |
|---|---|
| AMLODIPINE BESYLATE | 10 mg/1 |
| SPL SET ID: | 4b0616ab-8d0a-4310-b6b1-5d22c32a4da5 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 42582-315 | AMLODIPINE BESYLATE 10 mg | AMLODIPINE BESYLATE 10 mg |
| 62980-508 | AMLODIPINE BESYLATE 10 mg | AMLODIPINE BESYLATE 10 mg |
| 55700-740 | AMLODIPINE BESYLATE 10 mg | AMLODIPINE BESYLATE 10 mg |
| 0054-0100 | Amlodipine Besylate | Amlodipine Besylate |
| 0054-0101 | Amlodipine Besylate | Amlodipine Besylate |
| 0054-0102 | Amlodipine Besylate | Amlodipine Besylate |
| 0093-0083 | Amlodipine Besylate | Amlodipine Besylate |
| 0093-7167 | Amlodipine Besylate | Amlodipine Besylate |
| 0093-7168 | Amlodipine Besylate | Amlodipine Besylate |
| 0143-9959 | Amlodipine besylate | Amlodipine besylate |
| 0143-9960 | Amlodipine besylate | Amlodipine besylate |
| 0143-9961 | Amlodipine besylate | Amlodipine besylate |
| 0179-0210 | Amlodipine Besylate | Amlodipine Besylate |
| 0179-0211 | Amlodipine Besylate | Amlodipine Besylate |
| 0179-0213 | Amlodipine Besylate | Amlodipine Besylate |
| 0378-5208 | Amlodipine Besylate | amlodipine besylate |
| 0378-5209 | Amlodipine Besylate | amlodipine besylate |
| 0378-5210 | Amlodipine Besylate | amlodipine besylate |
| 0480-0083 | Amlodipine Besylate | Amlodipine Besylate |
| 0480-7167 | Amlodipine Besylate | Amlodipine Besylate |
| 0480-7168 | Amlodipine Besylate | Amlodipine Besylate |
| 0603-2108 | Amlodipine Besylate | amlodipine besylate |
| 0603-2109 | Amlodipine Besylate | amlodipine besylate |
| 0603-2110 | Amlodipine Besylate | amlodipine besylate |
| 0615-6577 | Amlodipine Besylate | amlodipine besylate |
| 0615-6578 | Amlodipine Besylate | amlodipine besylate |
| 0615-7939 | Amlodipine Besylate | Amlodipine Besylate |
| 0615-7941 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE |
| 0615-7942 | Amlodipine Besylate | Amlodipine Besylate |
| 0615-8199 | Amlodipine Besylate | Amlodipine Besylate |
| 0615-8200 | Amlodipine Besylate | Amlodipine Besylate |
| 0615-8201 | Amlodipine Besylate | Amlodipine Besylate |
| 0615-8282 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE |
| 0069-1520 | Norvasc | amlodipine besylate |
| 0069-1530 | Norvasc | amlodipine besylate |
| 0069-1540 | Norvasc | amlodipine besylate |