PillAmlodipine And Valsartan
Amlodipine Besylate + Valsartan
3 active makers
soon
soon
soon
soon
US acquisition costNADAC · per unit
Average across 16 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 it3 active · 0 exited
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 | unknown | 40 | SUPPLYING |
| Aurobindo Pharma Limited | unknown | 12 | SUPPLYING |
| Mylan Pharmaceuticals Inc. | unknown | 4 | SUPPLYING |
Regulatory & supply eventsFDA · US
Shortages, recalls, and registration changes attached to this drug concept.
- Dec 31, 2018RECALLRecall (Class II): Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, In…
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…
- Dec 31, 2018RECALLRecall (Class II): Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, I…
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…
- Dec 31, 2018RECALLRecall (Class II): Amlodipine and Valsartan Tablets USP 10 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, I…
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…
- Dec 31, 2018RECALLRecall (Class II): Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for: Aurobindo Pharma USA, Inc., Dayton…
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.
- Dec 31, 2018RECALLRecall (Class II): Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, I…
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…
- Dec 4, 2018RECALLRecall (Class II): Amlodipine and Valsartan Tablets, USP 10/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Phar…
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.
- Dec 4, 2018RECALLRecall (Class II): Amlodipine and Valsartan Tablets, USP 5/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Phar…
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.
- Dec 4, 2018RECALLRecall (Class II): Amlodipine and Valsartan Tablets, USP 5/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharm…
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.
- Dec 4, 2018RECALLRecall (Class II): Amlodipine and Valsartan Tablets, USP 10/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Phar…
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.
- Nov 20, 2018RECALLRecall (Class II): Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Ph…
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.
- Nov 20, 2018RECALLRecall (Class II): Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan P…
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.
- Nov 20, 2018RECALLRecall (Class II): Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Ph…
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.