Active ingredient
Darifenacin
16 finished FDA listings contain Darifenacin as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- DARIFENACIN, DARIFENACIN HYDROBROMIDE
- Dosage forms
- Tablet, Extended Release, Tablet, Film Coated, Extended Release
- Routes
- Oral
- Manufacturers / labelers
- 8
- Strengths listed
- 15 mg/1 · 7.5 mg/1
- Brand names in FDA listings
- Darifenacin
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 136198
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 207664 | CIPLA | 2016-09-01 | 2 |
| ANDA 206743 | AUROBINDO PHARMA | 2016-09-19 | 4 |
| ANDA 205209 | TORRENT | 2016-11-17 | 4 |
| ANDA 207302 | MACLEODS PHARMS | 2017-07-28 | 2 |
| ANDA 207681 | ALEMBIC | 2017-12-08 | 4 |
Official labeling on DailyMed
- DARIFENACIN TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED] · version 10 · 2026-03-03
- DARIFENACIN TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK] · version 100 · 2025-11-19
- DARIFENACIN TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK] · version 100 · 2025-11-19
- DARIFENACIN (DARIFENACIN HYDROBROMIDE) TABLET, EXTENDED RELEASE [CIPLA USA INC.] · version 9 · 2025-11-17
- DARIFENACIN TABLET, FILM COATED, EXTENDED RELEASE [RISING PHARMA HOLDINGS, INC.] · version 2 · 2024-05-01
- DARIFENACIN TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED] · version 5 · 2024-04-26
- DARIFENACIN TABLET, EXTENDED RELEASE [MACLEODS PHARMACEUTICALS LIMITED] · version 4 · 2023-02-17
- DARIFENACIN TABLET, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED] · version 3 · 2023-02-02
- DARIFENACIN TABLET, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS INC.] · version 8 · 2022-01-12
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.