Drug facts
MoleculePropranolol
Generics already compete: 18 makers on the market. 70 A-rated products from 18 makers substitute at the counter.
Propranolol was first approved by the FDA before 1982 under NDA 016419; the application holder is Baxter Healthcare Corp Anesthesia Critical Care. The Orange Book lists NDA 016419 as discontinued.
Propranolol Hydrochloride Injection is on the current FDA drug shortage list, first posted 10/31/2023.
Holder Baxter Healthcare Corp Anesthesia Critical CareApplication NDA 016419Approved 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 Propranolol patent listed in the Orange Book Orange Book
- Later patents, other products
- Hemangeol 10/16/2028 Orange Book
02Competition
- Generics
- 18 generic makers Orange Book
- First generic approved
- 07/30/1985 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 Propranolol profile.See what is included
03Supply and price
- FDA drug shortage
- ActivePropranolol Hydrochloride Injection is on the current shortage listsince 10/31/2023, unavailable FDA shortages
- NADAC
- $0.08 per unitPROPRANOLOL 40 MG TABLET, mid-priced of 5 strengths, as of 10/28/2026 CMS NADAC
- Latest recall
- 01/26/2022Class II, Propranolol Hydrochloride, Cardinal Healthcare FDA enforcement
04Product
- Application holder
- Baxter Healthcare Corp Anesthesia Critical Care Orange Book
- Application
- NDA 016419 Orange Book
- First approved
- before 1982 Orange Book
- Dosage forms
- capsule, extended release; injectable; solution; tablet
- Routes
- injection, oral
- Other brand names
- HemangeolInderal LAInnopran XL
- Status
- NDA 016419 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.