PillIrbesartan
Irbesartan
20 active makers
soon
soon
soon
soon
US acquisition costNADAC · per unit
Average across 39 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 it20 active · 1 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 | 30 | SUPPLYING |
| Bryant Ranch Prepack | repackager | 30 | SUPPLYING |
| Camber Pharmaceuticals, Inc. | unknown | 18 | SUPPLYING |
| Macleods Pharmaceuticals Limited | unknown | 15 | SUPPLYING |
| Proficient Rx LP | unknown | 13 | SUPPLYING |
| Amneal Pharmaceuticals LLC | unknown | 11 | SUPPLYING |
| Aurobindo Pharma Limited | unknown | 10 | SUPPLYING |
| Solco Healthcare US, LLC | unknown | 9 | SUPPLYING |
| Unichem Pharmaceuticals (USA), Inc. | unknown | 9 | SUPPLYING |
| Jubilant Cadista Pharmaceuticals Inc. | unknown | 9 | SUPPLYING |
| A-S Medication Solutions | unknown | 7 | SUPPLYING |
| ScieGen Pharmaceuticals, Inc. | unknown | 6 | SUPPLYING |
| Chartwell RX, LLC | unknown | 6 | SUPPLYING |
| REMEDYREPACK INC. | repackager | 5 | SUPPLYING |
| NorthStar RxLLC | unknown | 4 | SUPPLYING |
+ 6 more labelers
Regulatory & supply eventsFDA · US
Shortages, recalls, and registration changes attached to this drug concept.
- Jan 21, 2025RECALLRecall (Class II): Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. …
Out of Specification for Dissolution — Recalling firm: AvKARE — Nationwide in the USA
- Jul 18, 2022RECALLRecall (Class II): Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, Ind…
Failed Dissolution Specifications — Recalling firm: Jubilant Cadista Pharmaceuticals, Inc. — Nationwide within the United States
- Jul 18, 2022RECALLRecall (Class II): Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, In…
Failed dissolution specifications. — Recalling firm: Jubilant Cadista Pharmaceuticals, Inc. — Nationwide within the United States
- Oct 12, 2021RECALLRecall (Class II): Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only
CGMP Deviations: impurity N-nitrosoirbesartan detected in API — Recalling firm: Lupin Pharmaceuticals Inc. — Product was distributed to major distributors who may have further distributed the product nationwide.
- Oct 12, 2021RECALLRecall (Class II): Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) bottles, Rx only
CGMP Deviations: impurity N-nitrosoirbesartan detected in API — Recalling firm: Lupin Pharmaceuticals Inc. — Product was distributed to major distributors who may have further distributed the product nationwide.
- Oct 12, 2021RECALLRecall (Class II): Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles, Rx only
CGMP Deviations: impurity N-nitrosoirbesartan detected in API — Recalling firm: Lupin Pharmaceuticals Inc. — Product was distributed to major distributors who may have further distributed the product nationwide.
- Jan 18, 2019RECALLRecall (Class II): Irbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zh…
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