Active ingredient
Flavoxate
3 finished FDA listings contain Flavoxate as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- FLAVOXATE HYDROCHLORIDE
- Dosage forms
- Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 3
- Strengths listed
- 100 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 4440
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 076831 | PADAGIS US | 2004-12-16 | 1 |
| ANDA 076835 | EPIC PHARMA | 2005-11-30 | 2 |
Official labeling on DailyMed
- FLAVOXATE HYDROCHLORIDE TABLET [PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS] · version 6 · 2025-12-12
- FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [PADAGIS US LLC] · version 12 · 2025-11-17
- FLAVOXATE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] · version 11 · 2023-12-28
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.