Amlodipine Besylate + Valsartan
Average across 16 priced NDCs. A benchmark of pharmacy acquisition cost - not a retail quote.
Prescriptions dispensed under Medicaid (fee-for-service + managed care), summed nationally. The closest free proxy to sales volume - Medicaid only, not all-payer.
US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.
| Labeler | Type | Packages | Status |
|---|---|---|---|
| Alembic Pharmaceuticals Limited | generic | 40 | SUPPLYING |
| Aurobindo Pharma Limited | generic | 12 | SUPPLYING |
| Mylan Pharmaceuticals Inc. | generic | 4 | SUPPLYING |
Shortages, recalls, and registration changes attached to this drug concept.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. — Recalling firm: Aurobindo Pharma USA Inc. — Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout th…
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. — Recalling firm: Aurobindo Pharma USA Inc. — Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout th…
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. — Recalling firm: Aurobindo Pharma USA Inc. — Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout th…
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. — Recalling firm: Aurobindo Pharma USA Inc. — Product was distributed to major distribution chains throughout the United States.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. — Recalling firm: Aurobindo Pharma USA Inc. — Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout th…
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. — Recalling firm: Mylan Laboratories Limited, (Nashik FDF) — Product was distributed throughout the United States to several major distributors, including Puerto Rico.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. — Recalling firm: Mylan Laboratories Limited, (Nashik FDF) — Product was distributed throughout the United States to several major distributors, including Puerto Rico.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. — Recalling firm: Mylan Laboratories Limited, (Nashik FDF) — Product was distributed throughout the United States to several major distributors, including Puerto Rico.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. — Recalling firm: Mylan Laboratories Limited, (Nashik FDF) — Product was distributed throughout the United States to several major distributors, including Puerto Rico.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. — Recalling firm: Mylan Pharmaceuticals Inc. — Product was distributed throughout the United States.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. — Recalling firm: Mylan Pharmaceuticals Inc. — Product was distributed throughout the United States.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. — Recalling firm: Mylan Pharmaceuticals Inc. — Product was distributed throughout the United States.
