Active ingredient
Oxycodone
161 finished FDA listings contain Oxycodone as their only active ingredient; 137 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- OXYCODONE, OXYCODONE HYDROCHLORIDE
- Dosage forms
- Capsule, Capsule, Extended Release, Solution, Tablet, Tablet, Coated, Tablet, Film Coated, Extended Release
- Routes
- Oral
- Manufacturers / labelers
- 41
- Strengths listed
- 10 mg/1 · 100 mg/5ml · 13.5 mg/1 · 15 mg/1 · 18 mg/1 · 20 mg/1 · 20 mg/ml · 27 mg/1 · 30 mg/1 · 36 mg/1 · 40 mg/1 · 5 mg/1 · 5 mg/5ml · 60 mg/1 · 7.5 mg/1 · 80 mg/1 · 9 mg/1
- Brand names in FDA listings
- Oxaydo, Oxycodone Hydrochloride, Oxycontin, Roxicodone, Roxybond, Xtampza Er
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 7804
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 |
|---|---|---|---|
| NDA 021011 | SPECGX LLC | 2000-08-31 | 2 |
| ANDA 076758 | SPECGX LLC | 2004-06-30 | 7 |
| ANDA 077712 | STRIDES PHARMA INTL | 2007-01-31 | 17 |
| ANDA 091393 | AVANTHI INC | 2009-08-31 | 19 |
| NDA 022272 | KNOA PHARMA | 2010-04-05 | 8 |
| NDA 200535 | GENUS LIFESCIENCES | 2010-10-20 | 2 |
| ANDA 091490 | RHODES PHARMS | 2011-03-09 | 20 |
| NDA 202080 | ZYLA | 2011-06-17 | 2 |
| ANDA 202116 | ALVOGEN | 2011-12-30 | 6 |
| ANDA 202160 | AUROLIFE PHARMA LLC | 2012-11-19 | 5 |
| ANDA 204037 | HIKMA | 2013-07-15 | 2 |
| ANDA 203638 | AMNEAL PHARMS | 2014-06-03 | 15 |
| ANDA 204603 | NOVEL LABS INC | 2015-04-29 | 1 |
| ANDA 204979 | ANI PHARMS | 2015-06-01 | 3 |
| ANDA 202773 | AVANTHI INC | 2015-08-17 | 1 |
| ANDA 204752 | NOVEL LABS INC | 2015-08-24 | 1 |
| ANDA 202662 | EPIC PHARMA LLC | 2015-09-22 | 5 |
| ANDA 205177 | ANI PHARMS | 2016-03-31 | 1 |
| NDA 208090 | COLLEGIUM PHARM INC | 2016-04-26 | 5 |
| ANDA 207511 | ADAPTIS | 2016-11-23 | 4 |
| NDA 209777 | PROTEGA PHARMS | 2017-04-20 | 4 |
| ANDA 204021 | NOVEL LABS INC | 2017-06-12 | 6 |
| ANDA 208593 | ABHAI LLC | 2017-07-21 | 2 |
| ANDA 207418 | ASCENT PHARMS INC | 2017-08-07 | 12 |
| ANDA 209897 | ADAPTIS | 2017-09-06 | 1 |
| ANDA 209021 | ASCENT PHARMS INC | 2017-11-09 | 2 |
| ANDA 210758 | SPECGX LLC | 2018-04-30 | 2 |
| ANDA 206914 | PHARM ASSOC | 2019-02-01 | 2 |
| ANDA 212429 | AUROLIFE PHARMA LLC | 2020-01-27 | 2 |
| ANDA 213761 | QUAGEN | 2021-06-02 | 2 |
Official labeling on DailyMed
- OXYCODONE HYDROCHLORIDE CAPSULE [KVK-TECH, INC.] · version 12 · 2026-09-10
- OXYCODONE HYDROCHLORIDE TABLET [SPECGX LLC] · version 36 · 2026-08-10
- OXYCODONE HYDROCHLORIDE TABLET [ST. MARY'S MEDICAL PARK PHARMACY] · version 1 · 2026-08-07
- OXYCODONE HYDROCHLORIDE (OXYCODONE) TABLET [MAJOR PHARMACEUTICALS] · version 5 · 2026-08-03
- OXYCODONE HYDROCHLORIDE SOLUTION OXYCODONE HYDROCHLORIDE SOLUTION [KVK-TECH, INC.] · version 14 · 2026-07-31
- OXYCODONE HYDROCHLORIDE TABLET [ST. MARY'S MEDICAL PARK PHARMACY] · version 1 · 2026-07-30
- OXYCODONE HYDROCHLORIDE (OXYCODONE) TABLET [AMNEAL PHARMACEUTICALS LLC] · version 21 · 2026-07-16
- OXYCODONE HYDROCHLORIDE TABLET [ST. MARY'S MEDICAL PARK PHARMACY] · version 3 · 2026-07-15
- OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] · version 4 · 2026-07-15
- OXYCODONE HYDROCHLORIDE SOLUTION [EYWA PHARMA INC] · version 9 · 2026-07-13
- OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] · version 107 · 2026-06-30
- OXYCONTIN (OXYCODONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [KNOA PHARMA LLC] · version 44 · 2026-06-26
Showing the 12 most recent of 87 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.