Drug facts
MoleculeHydralazine
Generics already compete: 16 makers on the market. 38 A-rated products from 16 makers substitute at the counter.
Apresoline was first approved by the FDA before 1982 under NDA 008303; the application holder is Novartis Pharmaceuticals Corp. The Orange Book lists NDA 008303 as discontinued.
The latest NADAC for HYDRALAZINE 25 MG TABLET is $0.04 per unit (as of 10/28/2026).
Holder Novartis Pharmaceuticals CorpApplication NDA 008303Approved 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 Apresoline patent listed in the Orange Book Orange Book
02Competition
- Generics
- 16 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 Hydralazine profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.04 per unitHYDRALAZINE 25 MG TABLET, mid-priced of 4 strengths, as of 10/28/2026 CMS NADAC
- Latest recall
- 01/24/2025Class II, Hydralazine Hydrochloride, Sky Packaging FDA enforcement
04Product
- Application holder
- Novartis Pharmaceuticals Corp Orange Book
- Application
- NDA 008303 Orange Book
- First approved
- before 1982 Orange Book
- Dosage forms
- injectable; tablet
- Routes
- injection, oral
- Status
- NDA 008303 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.