Active ingredient
Tinidazole
13 finished FDA listings contain Tinidazole as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- TINIDAZOLE
- Dosage forms
- Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 7
- Strengths listed
- 250 mg/1 · 500 mg/1
- Brand names in FDA listings
- Tindamax, Tindazole
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 10612
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 021618 | MISSION PHARMA | 2004-05-17 | 3 |
| ANDA 202044 | CHARTWELL RX | 2012-04-30 | 4 |
| ANDA 202489 | UNIQUE | 2013-10-09 | 3 |
| ANDA 203808 | EDENBRIDGE PHARMS | 2015-08-04 | 3 |
Official labeling on DailyMed
- TINDAZOLE (TINIDAZOLE) TABLET, FILM COATED [REMEDYREPACK INC.] · version 3 · 2026-08-20
- TINIDAZOLE TABLET [REMEDYREPACK INC.] · version 1 · 2026-08-20
- TINIDAZOLE TABLET [EDENBRIDGE PHARMACEUTICALS LLC.] · version 9 · 2025-12-19
- TINIDAZOLE TABLET, FILM COATED [BIOCOMP PHARMA, INC.] · version 5 · 2025-12-04
- TINDAZOLE (TINIDAZOLE) TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.] · version 6 · 2025-09-22
- TINIDAZOLE TABLET, FILM COATED [CHARTWELL RX, LLC] · version 1 · 2024-07-19
- TINIDAZOLE TABLET [LUPIN PHARMACEUTICALS,INC.] · version 4 · 2023-06-23
- TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY] · version 9 · 2021-12-28
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.