PillIrbesartan And Hydrochlorothiazide
Hydrochlorothiazide + Irbesartan
6 active makers
soon
soon
soon
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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 it6 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 | 20 | SUPPLYING |
| Bryant Ranch Prepack | repackager | 8 | SUPPLYING |
| Solco Healthcare US, LLC | unknown | 6 | SUPPLYING |
| Hikma Pharmaceuticals USA Inc. | unknown | 4 | SUPPLYING |
| Proficient Rx LP | unknown | 3 | SUPPLYING |
| REMEDYREPACK INC. | repackager | 2 | SUPPLYING |
Regulatory & supply eventsFDA · US
Shortages, recalls, and registration changes attached to this drug concept.
- Jan 18, 2019RECALLRecall (Class II): Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co.…
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: Prinston Pharmaceutical Inc — Nationwide
- Jan 18, 2019RECALLRecall (Class II): Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co.…
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: Prinston Pharmaceutical Inc — Nationwide
- Jan 18, 2019RECALLRecall (Class II): Irbesartan and HydrochlorothiazideTablets, USP 150/12.5 mg Rx Only 90 count Manufactured by: Zhejiang Huahai Pharma…
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: Prinston Pharmaceutical Inc — Nationwide
- Jan 18, 2019RECALLRecall (Class II): Irbesartan and Hydrochlorothiazide Tablets, USP 150/12.5 mg Rx 30 Tablets Only Manufactured by: Zhejiang Huahai Pharmac…
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: Prinston Pharmaceutical Inc — Nationwide
- May 30, 2016RECALLRecall (Class III): Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, Rx only, Manufactured by: Zhejiang Huahai Pharmaceutical …
Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002 appears on the immediate container. — Recalling firm: Prinston Pharmaceutical Inc — Nationwide