PillBuprenorphine Hydrochloride
Buprenorphine Hydrochloride
3 active makers
soon
soon
soon
soon
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 |
|---|---|---|---|
| Par Health USA, LLC | unknown | 1 | SUPPLYING |
| Hikma Pharmaceuticals USA Inc. | unknown | 1 | SUPPLYING |
| Somerset Therapeutics, LLC | unknown | 1 | SUPPLYING |
Regulatory & supply eventsFDA · US
Shortages, recalls, and registration changes attached to this drug concept.
- Jun 12, 2026RECALLRecall (Class II): Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Int…
Crystallization; identified as Buprenorphine free base — Recalling firm: Par Health USA, LLC — Nationwide in the USA.
- Mar 13, 2026RECALLRecall (Class II): Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malver…
Crystallization; identified as Buprenorphine free base — Recalling firm: ENDO USA, Inc. — USA Nationwide
- Nov 9, 2021RECALLRecall (Class II): Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied …
Crystallization; identified as Buprenorphine free base — Recalling firm: PAR Sterile Products LLC — Nationwide USA
- Aug 14, 2020RECALLRecall (Class II): Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use Only, Rx Only, Manufactured by:…
Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing. — Recalling firm: Hikma Pharmaceuticals USA Inc. — Nationwide in the U.S.
- Apr 28, 2017RECALLRecall (Class II): Buprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-01), packaged in 1 mL x 5 Single Dose Vial…
Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component. — Recalling firm: PAR Sterile Products LLC — Nationwide in the USA