Drug facts
MoleculeTramadol
Generics already compete: 13 makers on the market. 21 A-rated products from 12 makers substitute at the counter.
Ultram was first approved by the FDA on 03/03/1995 under NDA 020281; the application holder is Janssen Pharmaceuticals Inc. The Orange Book lists NDA 020281 as discontinued.
The latest NADAC for TRAMADOL HCL 100 MG TABLET is $1.10 per unit (as of 10/28/2026).
Holder Janssen Pharmaceuticals IncApplication NDA 020281Approved 03/03/1995
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 Ultram patent listed in the Orange Book Orange Book
- Later patents, other products
- Qdolo 09/01/2040 Orange Book
02Competition
- Generics
- 13 generic makers Orange Book
- First generic approved
- 06/19/2002 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 Tramadol profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $1.10 per unitTRAMADOL HCL 100 MG TABLET, mid-priced of 3 strengths, as of 10/28/2026 CMS NADAC
- Latest recall
- 03/19/2026Class II, Tramadol Hydrochloride Tablets, Amneal Pharmaceuticals, LLC FDA enforcement
04Product
- Application holder
- Janssen Pharmaceuticals Inc Orange Book
- Application
- NDA 020281 Orange Book
- First approved
- 03/03/1995 Orange Book
- Dosage forms
- capsule, extended release; solution; tablet; tablet, extended release
- Routes
- oral
- Other brand names
- Conzip
- Status
- NDA 020281 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.