Drug facts
MoleculeHydrochlorothiazide
Generics already compete: 12 makers on the market. 27 A-rated products from 11 makers substitute at the counter.
Hydrodiuril was first approved by the FDA before 1982 under NDA 011835; the application holder is Merck and Co Inc. The Orange Book lists NDA 011835 as discontinued.
The latest NADAC for HYDROCHLOROTHIAZIDE 50 MG TAB is $0.03 per unit (as of 10/28/2026).
Holder Merck and Co IncApplication NDA 011835Approved 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 Hydrodiuril patent listed in the Orange Book Orange Book
- Later patents, other products
- Inzirqo 01/23/2044 Orange Book
02Competition
- Generics
- 12 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 Hydrochlorothiazide profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.03 per unitHYDROCHLOROTHIAZIDE 50 MG TAB, mid-priced of 3 strengths, as of 10/28/2026 CMS NADAC
04Product
- Application holder
- Merck and Co Inc Orange Book
- Application
- NDA 011835 Orange Book
- First approved
- before 1982 Orange Book
- Dosage forms
- capsule; for suspension; solution; tablet
- Routes
- oral
- Other brand names
- InzirqoMicrozide
- Status
- NDA 011835 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.