Active ingredient
Ondansetron
274 finished FDA listings contain Ondansetron as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ONDANSETRON, ONDANSETRON HYDROCHLORIDE
- Dosage forms
- Injection, Injection, Solution, Solution, Tablet, Tablet, Film Coated, Tablet, Orally Disintegrating
- Routes
- Intramuscular, Intravenous, Oral
- Manufacturers / labelers
- 78
- Strengths listed
- 16 mg/1 · 2 mg/ml · 24 mg/1 · 4 mg/1 · 4 mg/2ml · 4 mg/5ml · 8 mg/1
- Brand names in FDA listings
- Ondansetron, Ondansetron Odt
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 26225
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 077365 | HIKMA | 2006-12-26 | 2 |
| ANDA 077473 | HOSPIRA | 2006-12-26 | 2 |
| ANDA 076183 | DR REDDYS LABS LTD | 2006-12-26 | 11 |
| ANDA 076780 | HIKMA FARMACEUTICA | 2006-12-26 | 1 |
| ANDA 077541 | HIKMA | 2006-12-26 | 7 |
| ANDA 077548 | HOSPIRA | 2006-12-26 | 6 |
| ANDA 077406 | CHARTWELL MOLECULES | 2006-12-26 | 5 |
| ANDA 076781 | HIKMA FARMACEUTICA | 2006-12-26 | 2 |
| ANDA 076974 | FRESENIUS KABI USA | 2006-12-26 | 2 |
| ANDA 076960 | HIKMA | 2006-12-26 | 2 |
| ANDA 076972 | FRESENIUS KABI USA | 2006-12-26 | 3 |
| ANDA 077303 | CHARTWELL MOLECULES | 2007-06-25 | 2 |
| ANDA 077851 | NATCO PHARMA LTD | 2007-06-25 | 15 |
| ANDA 077050 | SUN PHARM INDS (IN) | 2007-06-25 | 2 |
| ANDA 077535 | GLENMARK PHARMS LTD | 2007-06-25 | 4 |
| ANDA 078127 | PHARM ASSOC | 2007-06-25 | 2 |
| ANDA 078152 | GLENMARK PHARMS LTD | 2007-06-27 | 29 |
| ANDA 078539 | AUROBINDO PHARMA | 2007-07-31 | 75 |
| ANDA 077557 | SUN PHARM INDS | 2007-08-02 | 8 |
| ANDA 078776 | AUROBINDO PHARMA | 2007-11-28 | 4 |
| ANDA 078257 | ONESOURCE SPECIALTY | 2008-04-23 | 1 |
| ANDA 078244 | ONESOURCE SPECIALTY | 2008-04-23 | 1 |
| ANDA 079224 | GLAND PHARMA LTD | 2009-09-25 | 5 |
| ANDA 090469 | AUROBINDO PHARMA | 2010-04-12 | 51 |
| ANDA 091342 | CHARTWELL MOLECULAR | 2011-01-27 | 2 |
| ANDA 091483 | AMNEAL PHARMS | 2011-01-31 | 4 |
| ANDA 090648 | GLAND PHARMA LTD | 2012-06-15 | 5 |
| ANDA 202600 | EUGIA PHARMA | 2012-12-21 | 1 |
| ANDA 202599 | EUGIA PHARMA | 2012-12-21 | 1 |
| ANDA 078287 | BAXTER HLTHCARE CORP | 2013-02-22 | 2 |
| ANDA 202253 | FRESENIUS KABI USA | 2013-07-19 | 2 |
| ANDA 203761 | IPCA LABS LTD | 2014-01-23 | 2 |
| ANDA 203711 | QILU PHARM HAINAN | 2014-09-08 | 7 |
| ANDA 206846 | ACCORD HLTHCARE | 2015-07-13 | 1 |
| ANDA 209389 | IPCA LABS LTD | 2023-10-30 | 5 |
Official labeling on DailyMed
- ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.] · version 6 · 2026-09-10
- ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP] · version 3 · 2026-09-07
- ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] · version 11 · 2026-09-02
- ONDANSETRON TABLET, FILM COATED [REMEDYREPACK INC.] · version 4 · 2026-09-02
- ONDANSETRON TABLET, ORALLY DISINTEGRATING [ASCLEMED USA, INC.] · version 4 · 2026-08-31
- ONDANSETRON TABLET, ORALLY DISINTEGRATING [ST. MARY'S MEDICAL PARK PHARMACY] · version 3 · 2026-08-28
- ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 6 · 2026-08-20
- ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [UNIT DOSE SOLUTIONS, INC.] · version 2 · 2026-08-20
- ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [IPCA LABORATORIES LIMITED] · version 1 · 2026-08-17
- ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY] · version 7 · 2026-08-17
- ONDANSETRON TABLET, ORALLY DISINTEGRATING [REMEDYREPACK INC.] · version 14 · 2026-08-12
- ONDANSETRON TABLET, ORALLY DISINTEGRATING [PREFERRED PHARMACEUTICALS, INC.] · version 7 · 2026-08-10
Showing the 12 most recent of 223 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.