Drug facts
MoleculeOndansetron Hydrochloride
Generics already compete: 18 makers on the market. 35 A-rated products from 18 makers substitute at the counter.
Zofran was first approved by the FDA on 01/04/1991 under NDA 020007; the application holder is Sandoz Inc. The Orange Book lists NDA 020007 as discontinued.
The latest NADAC for ONDANSETRON HCL 4 MG TABLET is $0.06 per unit (as of 10/28/2026).
Holder Sandoz IncApplication NDA 020007Approved 01/04/1991
01Patents and exclusivity
When competition can legally begin. A generic can launch once both exclusivity and the last listed patent expire, unless a court or settlement says otherwise.
- Latest patent
- No Zofran patent listed in the Orange Book Orange Book
02Competition
- Generics
- 18 generic makers Orange Book
- First generic approved
- 11/22/2006 Orange Book
Every listingEach listing and maker behind the generics count.
Price erosionHow NADAC moves as generics enter.
PrescribersWho prescribes it, from Medicare data.
Available in the full Ondansetron Hydrochloride profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.06 per unitONDANSETRON HCL 4 MG TABLET, as of 10/28/2026 CMS NADAC
- Latest recall
- 12/30/2025Class II, Ondansetron, Glenmark Pharmaceuticals Inc., USA FDA enforcement
04Product
- Application holder
- Sandoz Inc Orange Book
- Application
- NDA 020007 Orange Book
- First approved
- 01/04/1991 Orange Book
- Dosage forms
- injectable; solution; tablet
- Routes
- injection, oral
- Status
- NDA 020007 discontinued Orange Book
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.