Active ingredient
Oxybutynin
117 finished FDA listings contain Oxybutynin as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- OXYBUTYNIN, OXYBUTYNIN CHLORIDE
- Dosage forms
- Patch, Solution, Syrup, Tablet, Tablet, Extended Release, Tablet, Film Coated, Extended Release
- Routes
- Oral, Transdermal
- Manufacturers / labelers
- 42
- Strengths listed
- 10 mg/1 · 15 mg/1 · 2.5 mg/1 · 3.9 mg/d · 5 mg/1 · 5 mg/5ml
- Brand names in FDA listings
- Oxybutynin Chloride Extended Release, Oxytrol, Oxytrol For Women
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 32675
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 071655 | TEVA PHARMS USA | 1988-11-14 | 4 |
| ANDA 074520 | LANNETT CO INC | 1996-03-29 | 2 |
| ANDA 074625 | AIPING PHARM INC | 1996-07-31 | 2 |
| ANDA 075079 | STRIDES PHARMA INTL | 1997-10-31 | 3 |
| ANDA 075039 | CHARTWELL RX | 1999-01-29 | 2 |
| NDA 021351 | ALLERGAN | 2003-02-26 | 1 |
| ANDA 078503 | OSMOTICA PHARM US | 2009-02-04 | 19 |
| NDA 202211 | ABBVIE | 2013-01-25 | 1 |
| ANDA 204010 | AMNEAL PHARMS | 2015-11-23 | 4 |
| ANDA 207138 | ACCORD HLTHCARE | 2016-02-29 | 10 |
| ANDA 206121 | UNIQUE | 2016-05-27 | 9 |
| ANDA 202332 | ZYDUS PHARMS | 2017-06-26 | 10 |
| ANDA 209823 | NOVITIUM PHARMA | 2017-10-23 | 10 |
| ANDA 209025 | RISING | 2017-12-21 | 10 |
| ANDA 209335 | ABHAI LLC | 2017-12-22 | 8 |
| ANDA 210125 | TP ANDA HOLDINGS | 2018-09-06 | 3 |
| ANDA 211655 | AJANTA PHARMA LTD | 2019-02-28 | 6 |
| ANDA 211682 | HERITAGE PHARMA AVET | 2019-05-10 | 1 |
| ANDA 212798 | LEADING | 2020-04-06 | 4 |
| ANDA 214415 | RUBICON RESEARCH | 2020-10-27 | 3 |
| ANDA 208165 | STRIDES PHARMA | 2020-12-17 | 5 |
Official labeling on DailyMed
- OXYBUTYNIN CHLORIDE TABLET [RISING PHARMA HOLDINGS, INC.] · version 2 · 2026-08-07
- OXYBUTYNIN CHLORIDE TABLET [TRUPHARMA LLC] · version 6 · 2026-07-29
- OXYBUTYNIN CHLORIDE TABLET [REMEDYREPACK INC.] · version 10 · 2026-07-29
- OXYBUTYNIN CHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORP.] · version 4 · 2026-07-13
- OXYBUTYNIN CHLORIDE TABLET [COUPLER LLC] · version 1 · 2026-07-07
- OXYBUTYNIN CHLORIDE TABLET [STRIDES PHARMA SCIENCE LIMITED] · version 7 · 2026-07-02
- OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] · version 13 · 2026-06-26
- OXYBUTYNIN CHLORIDE TABLET [STRIDES PHARMA SCIENCE LIMITED] · version 6 · 2026-06-03
- OXYBUTYNIN CHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] · version 2 · 2026-06-02
- OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK] · version 5 · 2026-05-21
- OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK] · version 102 · 2026-05-20
- OXYBUTYNIN CHLORIDE TABLET [AMERICAN HEALTH PACKAGING] · version 2 · 2026-04-17
Showing the 12 most recent of 85 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.