Drug facts
MoleculeFamotidine (Pepcid AC)
Generics already compete: 39 makers on the market. 63 A-rated products from 33 makers substitute at the counter.
Pepcid was first approved by the FDA on 10/15/1986 under NDA 019462; the application holder is Bausch Health US LLC. The Orange Book lists NDA 019462 as discontinued.
The latest NADAC for FAMOTIDINE 40 MG TABLET is $0.05 per unit (as of 10/28/2026).
Holder Bausch Health US LLCApplication NDA 019462Approved 10/15/1986
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 Pepcid patent listed in the Orange Book Orange Book
02Competition
- Generics
- 39 generic makers Orange Book
- First generic approved
- 04/16/2001 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 Famotidine profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.05 per unitFAMOTIDINE 40 MG TABLET, mid-priced of 3 strengths, as of 10/28/2026 CMS NADAC
- Latest recall
- 08/06/2026Class II, Famotidine, Baxter Healthcare Corporation FDA enforcement
04Product
- Application holder
- Bausch Health US LLC Orange Book
- Application
- NDA 019462 Orange Book
- First approved
- 10/15/1986 Orange Book
- Dosage forms
- for suspension; injectable; tablet; tablet, chewable
- Routes
- injection, oral
- Status
- NDA 019462 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.