AMLODIPINE BESYLATE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Amlodipine Besylate.
| Product ID | 61919-782_48f94245-3a9e-0b7c-e054-00144ff88e88 |
| NDC | 61919-782 |
| Product Type | Human Prescription Drug |
| Proprietary Name | AMLODIPINE BESYLATE |
| Generic Name | Amlodipine Besylate |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-02-20 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA203245 |
| Labeler Name | DIRECT RX |
| 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 | E |
| Listing Certified Through | 2018-12-31 |
| Marketing Start Date | 2019-07-29 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA203245 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-02-21 |
| Marketing Category | ANDA |
| Application Number | ANDA203245 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-02-20 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA203245 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-07-29 |
| Ingredient | Strength |
|---|---|
| AMLODIPINE BESYLATE | 10 mg/1 |
| SPL SET ID: | 4910c9c2-d290-38c4-e054-00144ff8d46c |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 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 |
| 0615-6582 | Amlodipine Besylate | Amlodipine |
| 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 |
| 67544-979 | Amlodipine Besylate | Amlodipine Besylate |
| 67544-993 | Amlodipine Besylate | Amlodipine Besylate |
| 67877-198 | Amlodipine Besylate | Amlodipine Besylate |
| 67877-197 | Amlodipine Besylate | Amlodipine Besylate |
| 67877-199 | Amlodipine Besylate | Amlodipine Besylate |
| 68071-1902 | Amlodipine Besylate | Amlodipine Besylate |
| 68071-1974 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE |
| 68071-1924 | Amlodipine Besylate | Amlodipine Besylate |
| 68071-1903 | Amlodipine Besylate | Amlodipine Besylate |
| 68071-3188 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE |
| 68071-1980 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE |
| 68071-4251 | Amlodipine Besylate | Amlodipine Besylate |
| 68071-3327 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE |
| 68071-4776 | Amlodipine Besylate | Amlodipine Besylate |
| 68151-0995 | Amlodipine Besylate | Amlodipine Besylate |
| 68180-720 | Amlodipine Besylate | Amlodipine Besylate |
| 68180-750 | Amlodipine Besylate | Amlodipine Besylate |
| 68180-721 | Amlodipine Besylate | Amlodipine Besylate |
| 68180-752 | Amlodipine Besylate | Amlodipine Besylate |