Active ingredient
Diflunisal
7 finished FDA listings contain Diflunisal as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- DIFLUNISAL
- Dosage forms
- Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 6
- Strengths listed
- 250 mg/1 · 375 mg/1 · 500 mg/1
- Brand names in FDA listings
- Dolobid
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 3393
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 073673 | TEVA | 1992-07-31 | 1 |
| ANDA 202845 | HERITAGE PHARMA | 2012-03-08 | 4 |
| ANDA 203547 | ZYDUS PHARMS | 2017-06-16 | 2 |
Official labeling on DailyMed
- DIFLUNISAL TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] · version 14 · 2026-08-07
- DOLOBID (DIFLUNISAL) TABLET, FILM COATED [INA PHARMACEUTICS INC] · version 4 · 2025-11-17
- DIFLUNISAL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] · version 21 · 2024-12-19
- DIFLUNISAL TABLET [ZYDUS LIFESCIENCES LIMITED] · version 5 · 2024-11-25
- DIFLUNISAL TABLET, FILM COATED [CHARTWELL RX, LLC] · version 2 · 2024-10-14
- DIFLUNISAL TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] · version 5 · 2024-08-06
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.