Active ingredient
Ciprofloxacin
202 finished FDA listings contain Ciprofloxacin as their only active ingredient; 19 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE
- Dosage forms
- Injection, Solution, Ointment, Solution, Solution/ Drops, Tablet, Tablet, Coated, Tablet, Film Coated
- Routes
- Auricular (Otic), Intravenous, Ophthalmic, Oral
- Manufacturers / labelers
- 57
- Strengths listed
- .5 mg/.25ml · 2 mg/ml · 200 mg/100ml · 250 mg/1 · 3 mg/g · 3 mg/ml · 400 mg/200ml · 500 mg/1 · 750 mg/1
- Brand names in FDA listings
- Ciloxan, Cipro, Ciprofloxacin, Ciprofloxacin Hcl Ophthalmic, Ciprofloxacin In Dextrose, Ciprofloxacin Otic
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2551
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 019537 | BAYER HLTHCARE | 1987-10-22 | 2 |
| NDA 019992 | SANDOZ | 1990-12-31 | 11 |
| NDA 020369 | SANDOZ | 1998-03-30 | 1 |
| ANDA 076593 | AIPING PHARM INC | 2004-03-16 | 13 |
| ANDA 076558 | HIKMA | 2004-06-09 | 17 |
| ANDA 075939 | AMNEAL | 2004-06-09 | 3 |
| ANDA 075928 | RUBICON RESEARCH | 2004-06-09 | 1 |
| ANDA 076126 | CARLSBAD | 2004-06-09 | 18 |
| ANDA 076794 | WATSON LABS | 2004-06-09 | 3 |
| ANDA 076639 | UNIQUE | 2004-09-10 | 27 |
| ANDA 076896 | CHARTWELL | 2004-11-04 | 3 |
| ANDA 077859 | AUROBINDO PHARMA | 2007-04-26 | 37 |
| ANDA 078252 | INFORLIFE | 2008-03-18 | 5 |
| ANDA 077568 | FDC LTD | 2008-06-30 | 11 |
| ANDA 204613 | ALTAIRE PHARMS INC | 2018-05-03 | 1 |
| ANDA 208921 | YILING | 2018-06-22 | 48 |
| ANDA 217887 | ALEMBIC THERAP | 2024-11-05 | 1 |
Official labeling on DailyMed
- CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REMEDYREPACK INC.] · version 6 · 2026-09-02
- CIPROFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] · version 4 · 2026-08-28
- CIPROFLOXACIN TABLET, FILM COATED [CARDINAL HEALTH 107, LLC] · version 3 · 2026-08-25
- CIPROFLOXACIN (CIPROFOLXACIN) TABLET [NUCARE PHARMACEUTICAL, INC.] · version 3 · 2026-08-24
- CIPROFLOXACIN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] · version 4 · 2026-08-17
- CIPROFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP] · version 5 · 2026-08-10
- CIPROFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [COUPLER LLC] · version 1 · 2026-08-06
- CIPROFLOXACIN TABLET, FILM COATED [REMEDYREPACK INC.] · version 15 · 2026-08-05
- CIPROFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC] · version 1 · 2026-08-03
- CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REDPHARM DRUG] · version 1 · 2026-08-03
- CIPROFLOXACIN TABLET, FILM COATED [REMEDYREPACK INC.] · version 11 · 2026-07-31
- CIPROFLOXACIN TABLET, FILM COATED [NORTHWIND HEALTH COMPANY, LLC] · version 2 · 2026-07-31
Showing the 12 most recent of 166 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.