PillValsartan And Hydrochlorothiazide
Hydrochlorothiazide + Valsartan
1 active makers
soon
soon
soon
soon
US acquisition costNADAC · per unit
Average across 8 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 it1 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 |
|---|---|---|---|
| Aurobindo Pharma Limited | unknown | 14 | SUPPLYING |
Regulatory & supply eventsFDA · US
Shortages, recalls, and registration changes attached to this drug concept.
- Dec 31, 2018RECALLRecall (Class II): Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Phar…
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): Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharm…
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): Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Phar…
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): Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Phar…
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): Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Phar…
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…