Drug
Who makes amlodipine besylate?
42 companies list amlodipine besylate as a human prescription drug, including under the names Norvasc. Forms: tablet. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing amlodipine besylate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Aphena Pharma Solutions - Tennessee, LLC | tablet | ANDA, NDA AUTHORIZED GENERICANDA076719, ANDA076846, ANDA077955 | 17 | 0 |
| International Medication Systems, Ltd.United States | tablet | ANDAANDA078043, ANDA078925, ANDA203245 | 14 | 3 |
| Bryant Ranch PrepackUnited States | tablet | ANDAANDA077073, ANDA077516, ANDA077955 | 14 | 1 |
| Proficient Rx LPUnited States | tablet | ANDAANDA077073, ANDA078043, ANDA078414 | 11 | 1 |
| PD-Rx Pharmaceuticals Inc.United States | tablet | ANDAANDA076719, ANDA077073, ANDA078414 | 9 | 1 |
| Preferred Pharmaceuticals Inc.United States | tablet | ANDAANDA077073, ANDA078043, ANDA078414 | 8 | 1 |
| RemedyRepack, IncUnited States | tablet | ANDAANDA077073, ANDA078925, ANDA203245 | 8 | 1 |
| NuCare Pharmaceuticals,Inc.United States | tablet | ANDAANDA077073, ANDA078043, ANDA078414 | 7 | 1 |
| CIPLA PHARMACEUTICALS LIMITEDIndia | tablet | ANDAANDA077073, ANDA077955 | 6 | 7 |
| NCS HealthCare of KY, LLC dba Vangard LabsUnited States | tablet | ANDAANDA078925 | 6 | 1 |
| ASCEND Therapeutics US, LLC | tablet | ANDAANDA078925 | 6 | 0 |
| Exelan Pharmaceuticals, Inc. | tablet | ANDAANDA077955, ANDA206367 | 6 | 0 |
| Northwind Health Company, LLCUnited States | tablet | ANDAANDA077073, ANDA078925, ANDA203245 | 5 | 1 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet | ANDAANDA078925 | 4 | 5 |
| Cardinal Health 418, Inc.United States | tablet | ANDAANDA078226 | 3 | 34 |
| Viatris Inc.India | tablet | NDANDA019787 | 3 | 18 |
| Lupin LimitedIndia | tablet | ANDAANDA078043 | 3 | 14 |
| Zydus Lifesciences LimitedIndia | tablet | ANDAANDA078226 | 3 | 12 |
| Aurobindo Pharma LimitedIndia | tablet | ANDAANDA078021 | 3 | 6 |
| Teva Pharmaceutical Industries Ltd.Canada | tablet | ANDAANDA076846 | 3 | 6 |
| Unichem Laboratories Limited, IndiaIndia | tablet | ANDAANDA203245 | 3 | 5 |
| Epic Laboratories, LLCUnited States | tablet | ANDAANDA078552 | 3 | 3 |
| Safecor Health, LLCUnited States | tablet | ANDAANDA078226 | 3 | 3 |
| China Resources Saike Pharmaceutical Co., Ltd.China | tablet | ANDAANDA090752 | 3 | 1 |
| Direct RxUnited States | tablet | ANDAANDA078925, ANDA203245 | 3 | 1 |
| Oxford Pharmaceuticals, LLCUnited States | tablet | ANDAANDA078414 | 3 | 1 |
| POLYGEN PHARMACEUTICALS INC.United States | tablet | ANDAANDA207821 | 3 | 1 |
| Zydus Pharmaceuticals USA Inc.India | tablet | ANDAANDA078226 | 3 | 1 |
| AvKARE | tablet | ANDAANDA076846 | 3 | 0 |
| Legacy Pharmaceutical Packaging, LLC | tablet | ANDAANDA077955, ANDA078552 | 3 | 0 |
| MAJOR Pharmaceuticals Inc. | tablet | ANDAANDA078226 | 3 | 0 |
| Mylan Pharmaceuticals, Inc. | tablet | NDA AUTHORIZED GENERICNDA019787 | 3 | 0 |
| Pfizer Laboratories Div Pfizer Inc | tablet | NDANDA019787 | 3 | 0 |
| Quallent Pharmaceuticals Health, LLC | tablet | ANDAANDA077073 | 3 | 0 |
| Coupler LLCUnited States | tablet | ANDAANDA078043, ANDA078925 | 2 | 1 |
| QPharma IncUnited States | tablet | ANDAANDA078925 | 2 | 1 |
| RedPharm DrugUnited States | tablet | ANDAANDA077073, ANDA203245 | 2 | 1 |
| Unit Dose Solutions, Inc.United States | tablet | ANDAANDA078925 | 2 | 1 |
| GSMS, Incorporated | tablet | ANDAANDA076719 | 2 | 0 |
| Quality Care Products, LLC | tablet | ANDAANDA078925, ANDA203245 | 2 | 0 |
| Boswell Pharmacy Services LLCUnited States | tablet | ANDAANDA203245 | 1 | 1 |
| St. Mary's Medical Park PharmacyUnited States | tablet | ANDAANDA203245 | 1 | 1 |
Bulk ingredient listings
- Arene Life Sciences Private LimitedIndia · 1 NDC
- Aurobindo Pharma LimitedIndia · 1 NDC
- Aurore Pharmaceuticals Private LimitedIndia · 1 NDC
- CIPLA PHARMACEUTICALS LIMITEDIndia · 1 NDC
- Cadila Pharmaceuticals LimitedIndia · 1 NDC
- Darmerica, LLCUnited States · 1 NDC
- Dasami Lab Private LimitedIndia · 1 NDC
- Dr. Reddy's Laboratories LimitedIndia · 1 NDC
- Fagron Services B.V.Netherlands · 1 NDC
- Hetero Drugs LimitedIndia · 1 NDC
- Ipca Laboratories LimitedIndia · 1 NDC
- Lee Pharma LimitedIndia · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- Malladi Drugs & Pharmaceuticals LimitedIndia · 1 NDC
- Matrix Pharmacorp Private LimitedIndia · 1 NDC
- Moehs Catalana SLSpain · 1 NDC
- NURAY CHEMICALS PRIVATE LIMITEDIndia · 1 NDC
- Novartis Pharmaceuticals CorporationSwitzerland · 1 NDC
- Pfizer IncUnited States · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- SRINI PHARMACEUTICALS PRIVATE LIMITEDIndia · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
- Unichem Laboratories Limited, IndiaIndia · 1 NDC
- Viatris Inc.India · 1 NDC
- XENEX LABORATORIES INCCanada · 1 NDC
- Zhejiang Huahai Pharmaceutical Technology Co LtdChina · 1 NDC
- Zydus Lifesciences LimitedIndia · 1 NDC
Orange Book patents
6 unexpired patents list amlodipine besylate as the active ingredient, expiring between Feb 2041 and Feb 2041. Application holder: CMP DEVELOPMENT LLC.
Enquiry
Common questions
- Who makes amlodipine besylate?
- 42 companies list amlodipine besylate as a human prescription drug in the openFDA NDC Directory, led by Aphena Pharma Solutions - Tennessee, LLC, International Medication Systems, Ltd., Bryant Ranch Prepack, Proficient Rx LP, PD-Rx Pharmaceuticals Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Norvasc?
- 39 companies list amlodipine besylate under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies amlodipine besylate active ingredient?
- 27 companies list amlodipine besylate as a bulk ingredient, including Arene Life Sciences Private Limited, Aurobindo Pharma Limited, Aurore Pharmaceuticals Private Limited, CIPLA PHARMACEUTICALS LIMITED.