Amlodipine Besylate
Brands: Norvasc · Amlodipine Besylate
40 active makers
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US acquisition costNADAC · per unit
Average across 99 priced NDCs. A benchmark of pharmacy acquisition cost — not a retail quote.
Medicaid dispensing volumeSDUD · per quarter
Prescriptions dispensed under Medicaid (fee-for-service + managed care), summed nationally. The closest free proxy to sales volume — Medicaid only, not all-payer.
Who makes it40 active · 2 exited
US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.
| Labeler | Type | Packages | Status |
|---|---|---|---|
| Bryant Ranch Prepack | repackager | 122 | SUPPLYING |
| Aphena Pharma Solutions - Tennessee, LLC | unknown | 56 | SUPPLYING |
| Proficient Rx LP | unknown | 42 | SUPPLYING |
| Preferred Pharmaceuticals Inc. | unknown | 32 | SUPPLYING |
| A-S Medication Solutions | unknown | 28 | SUPPLYING |
| PD-Rx Pharmaceuticals, Inc. | unknown | 25 | SUPPLYING |
| Ascend Laboratories, LLC | unknown | 20 | SUPPLYING |
| Exelan Pharmaceuticals, Inc. | unknown | 18 | SUPPLYING |
| REMEDYREPACK INC. | repackager | 17 | SUPPLYING |
| NuCare Pharmaceuticals, Inc. | unknown | 14 | SUPPLYING |
| NCS HealthCare of KY, LLC dba Vangard Labs | unknown | 14 | SUPPLYING |
| Zydus Lifesciences Limited | unknown | 12 | SUPPLYING |
| Cipla USA Inc. | unknown | 12 | SUPPLYING |
| Zydus Pharmaceuticals USA Inc. | unknown | 12 | SUPPLYING |
| Oxford Pharmaceuticals, LLC | unknown | 12 | SUPPLYING |
+ 27 more labelers
Regulatory & supply eventsFDA · US
Shortages, recalls, and registration changes attached to this drug concept.
- Jun 27, 2023RECALLRecall (Class III): Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Balt…
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study. — Recalling firm: Lupin Pharmaceuticals Inc. — Product was distributed directly to three distributors in TN and NJ. Product may have been further distributed througho…
- Oct 3, 2018RECALLRecall (Class III): Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manu…
Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition. — Recalling firm: InvaGen Pharmaceuticals, Inc. — Nationwide with the United States
- May 5, 2017RECALLRecall (Class III): AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - …
PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg. — Recalling firm: Ascend Laboratories LLC — Nationwide in the USA.
- Feb 19, 2016RECALLRecall (Class III): Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltim…
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. — Recalling firm: Lupin Limited — US No recalled product was distributed to any foreign consignees by Lupin.
- Feb 19, 2016RECALLRecall (Class III): Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Balti…
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. — Recalling firm: Lupin Limited — US No recalled product was distributed to any foreign consignees by Lupin.
- Oct 1, 2014RECALLRecall (Class III): Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedab…
Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344. — Recalling firm: Zydus Pharmaceuticals USA Inc — Nationwide
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