Active ingredient
Buprenorphine
106 finished FDA listings contain Buprenorphine as their only active ingredient; 104 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- BUPRENORPHINE, BUPRENORPHINE HYDROCHLORIDE
- Dosage forms
- Film, Soluble, Injection, Injection, Solution, Patch, Patch, Extended Release, Solution, Tablet
- Routes
- Buccal, Intramuscular, Intravenous, Subcutaneous, Sublingual, Transdermal
- Manufacturers / labelers
- 32
- Strengths listed
- .3 mg/ml · .324 mg/ml · 10 ug/h · 100 mg/1 · 12 mg/1 · 128 mg/.36ml · 15 ug/h · 150 ug/1 · 16 mg/.32ml · 2 mg/1 · 20 ug/h · 24 mg/.48ml · 300 mg/1 · 300 ug/1 · 32 mg/.64ml · 4 mg/1 · 450 ug/1 · 5 ug/h · 600 ug/1 · 64 mg/.18ml · 7.5 ug/h · 75 ug/1 · 750 ug/1 · 8 mg/.16ml · 8 mg/1 · 900 ug/1 · 96 mg/.27ml
- Brand names in FDA listings
- Belbuca, Brixadi, Buprenorphine Transdermal System, Butrans, Sublocade
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1819
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 074137 | HOSPIRA | 1996-06-03 | 1 |
| ANDA 076931 | HIKMA | 2005-03-02 | 1 |
| ANDA 078633 | HIKMA | 2009-10-08 | 12 |
| NDA 021306 | KNOA PHARMA | 2010-06-30 | 10 |
| ANDA 090622 | ETHYPHARM | 2010-09-24 | 4 |
| ANDA 090819 | ACTAVIS ELIZABETH | 2015-02-19 | 3 |
| ANDA 090279 | RUBICON RESEARCH | 2015-06-10 | 5 |
| ANDA 206586 | PH HEALTH | 2015-07-28 | 1 |
| NDA 207932 | BDSI | 2015-10-23 | 7 |
| ANDA 201760 | SUN PHARM | 2016-01-29 | 9 |
| ANDA 207276 | RHODES PHARMS | 2017-03-27 | 14 |
| NDA 209819 | INDIVIOR | 2017-11-30 | 2 |
| ANDA 204937 | WATSON LABS TEVA | 2018-11-20 | 5 |
| ANDA 211586 | AMNEAL | 2020-04-14 | 5 |
| ANDA 210272 | DIFGEN PHARMS | 2021-09-23 | 10 |
| ANDA 207490 | STRIDES PHARMA INTL | 2022-05-17 | 5 |
| NDA 210136 | BRAEBURN | 2023-05-23 | 7 |
| ANDA 219302 | SOMERSET THERAPS LLC | 2025-01-30 | 1 |
| ANDA 218473 | SPECGX LLC | 2025-12-10 | 2 |
| ANDA 219401 | ASCENT PHARMS INC | 2025-12-18 | 2 |
Official labeling on DailyMed
- BUPRENORPHINE HYDROCHLORIDE TABLET [PAI HOLDINGS, LLC DBA PAI PHARMA] · version 7 · 2026-08-13
- BUPRENORPHINE HCL TABLET [SPECGX LLC] · version 3 · 2026-08-06
- BUPRENORPHINE TABLET [ACTAVIS PHARMA, INC.] · version 35 · 2026-07-30
- SUBLOCADE (BUPRENORPHINE) SOLUTION [INDIVIOR INC.] · version 43 · 2026-07-28
- BUPRENORPHINE HYDROCHLORIDE TABLET [ADVAGEN PHARMA LTD] · version 7 · 2026-07-20
- BUPRENORPHINE HCL TABLET [REMEDYREPACK INC.] · version 17 · 2026-07-20
- BUPRENORPHINE HCL TABLET [REMEDYREPACK INC.] · version 18 · 2026-07-15
- BUPRENORPHINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.] · version 3 · 2026-07-09
- BUPRENORPHINE TABLET [REMEDYREPACK INC.] · version 5 · 2026-07-08
- BUPRENORPHINE TABLET [BRYANT RANCH PREPACK] · version 1 · 2026-07-03
- BUPRENORPHINE TABLET [UNIT DOSE SOLUTIONS, INC.] · version 1 · 2026-07-01
- BUPRENORPHINE TABLET [BRYANT RANCH PREPACK] · version 112 · 2026-06-30
Showing the 12 most recent of 50 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.