PillValsartan And Hydrochlorothiazide
Brands: Diovan Hct · Hydrochlorothiazide + Valsartan
16 active makers
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US acquisition costNADAC · per unit
Average across 33 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 it16 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 |
| Proficient Rx LP | unknown | 29 | SUPPLYING |
| Amneal Pharmaceuticals LLC | unknown | 20 | SUPPLYING |
| Bryant Ranch Prepack | repackager | 16 | SUPPLYING |
| Zydus Lifesciences Limited | unknown | 15 | SUPPLYING |
| Solco Healthcare US, LLC | unknown | 15 | SUPPLYING |
| A-S Medication Solutions | unknown | 11 | SUPPLYING |
| Macleods Pharmaceuticals Limited | unknown | 8 | SUPPLYING |
| AvKARE | unknown | 5 | SUPPLYING |
| Mylan Pharmaceuticals Inc. | unknown | 5 | SUPPLYING |
| Novartis Pharmaceuticals Corporation | unknown | 5 | SUPPLYING |
| Amneal Pharmaceuticals of New York LLC | unknown | 5 | SUPPLYING |
| Aurobindo Pharma Limited | unknown | 4 | SUPPLYING |
| Northwind Health Company, LLC | unknown | 4 | SUPPLYING |
| Preferred Pharmaceuticals Inc. | unknown | 3 | SUPPLYING |
+ 1 more labelers
Regulatory & supply eventsFDA · US
Shortages, recalls, and registration changes attached to this drug concept.
- Dec 4, 2018RECALLRecall (Class II): Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg, (a) 90-count bottle (NDC 0378-6324-77), (b) 500-count bottl…
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): Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bottle (NDC 0378-6322-77), (b) 500-count bottl…
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): Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg, (a) 90-count bottle (NDC 0378-6323-77), (b) 500-count bottles…
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): Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottle (NDC 0378-6321-77), (b) 500-count bottle…
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): Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle (NDC 0378-6325-77), (b) 500-count bottles…
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): Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx Only, Made in India, Manufacture…
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.
- Jul 13, 2018RECALLRecall (Class II): Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 80 MG/12.5 MG Tablets, 90-count bottles, Rx Only, Manufactu…
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. — Recalling firm: Prinston Pharmaceutical Inc — United States
- Jul 13, 2018RECALLRecall (Class II): Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tablets, 90-count bottle, Rx Only, Manufacture…
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. — Recalling firm: Prinston Pharmaceutical Inc — United States
- Jul 13, 2018RECALLRecall (Class II): Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/12.5 MG Tablets, 90-count bottles, Rx Only, Manufact…
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. — Recalling firm: Prinston Pharmaceutical Inc — United States
- Jul 13, 2018RECALLRecall (Class II): Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 MG Tablets, 90-count bottles, Rx Only, Manufactur…
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. — Recalling firm: Prinston Pharmaceutical Inc — United States
- Jul 13, 2018RECALLRecall (Class II): Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/12.5 MG Tablets, 90-count bottle, Rx Only, Manufactu…
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. — Recalling firm: Prinston Pharmaceutical Inc — United States