Drug facts
MoleculeAzithromycin (Zithromax)
Generics already compete: 19 makers on the market. 45 A-rated products from 19 makers substitute at the counter.
Zithromax was first approved by the FDA on 11/01/1991 under NDA 050670; the application holder is Pfizer Chemicals Div Pfizer Inc. The Orange Book lists NDA 050670 as discontinued.
The latest NADAC for AZITHROMYCIN 500 MG TABLET is $0.55 per unit (as of 10/28/2026).
Holder Pfizer Chemicals Div Pfizer IncApplication NDA 050670Approved 11/01/1991
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 Zithromax patent listed in the Orange Book Orange Book
02Competition
- Generics
- 19 generic makers Orange Book
- First generic approved
- 11/14/2005 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 Azithromycin profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.55 per unitAZITHROMYCIN 500 MG TABLET, mid-priced of 3 strengths, as of 10/28/2026 CMS NADAC
- Latest recall
- 04/13/2022Class II, Azithromycin, Mckesson Medical-Surgical Inc. Corporate Office FDA enforcement
04Product
- Application holder
- Pfizer Chemicals Div Pfizer Inc Orange Book
- Application
- NDA 050670 Orange Book
- First approved
- 11/01/1991 Orange Book
- Dosage forms
- for suspension; injectable; solution/drops; tablet
- Routes
- injection, ophthalmic, oral
- Other brand names
- Azasite
- Status
- NDA 050670 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.