Drug facts
MoleculeHydroxyzine Hydrochloride
Generics already compete: 19 makers on the market. 41 A-rated products from 18 makers substitute at the counter.
Atarax was first approved by the FDA before 1982 under NDA 010392; the application holder is Pfizer Inc. The Orange Book lists NDA 010392 as discontinued.
The latest NADAC for HYDROXYZINE HCL 25 MG TABLET is $0.03 per unit (as of 10/28/2026).
Holder Pfizer IncApplication NDA 010392Approved before 1982
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 Atarax patent listed in the Orange Book Orange Book
02Competition
- Generics
- 19 generic makers Orange Book
- First generic approved
- before 1982 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 Hydroxyzine Hydrochloride profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.03 per unitHYDROXYZINE HCL 25 MG TABLET, mid-priced of 3 strengths, as of 10/28/2026 CMS NADAC
- Latest recall
- 06/02/2026Class III, Hydroxyzine Hydrochloride, Ani Pharmaceuticals, Inc. FDA enforcement
04Product
- Application holder
- Pfizer Inc Orange Book
- Application
- NDA 010392 Orange Book
- First approved
- before 1982 Orange Book
- Dosage forms
- injectable; syrup; tablet
- Routes
- injection, oral
- Status
- NDA 010392 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.