Active substance
Orphenadrine
- US FDA 16
- Health Canada 1
- US price lines 3
- NHS prices 1
- Safety 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| ORPHENADRINE CITRATE | 30MG/ML | injectable · injection | WATSON LABS | Prescription | 15 Mar 1982 |
| ORPHENADRINE CITRATE | 100MG | tablet, extended release · oral | LUPIN | Prescription | 19 Jun 1998 |
| ORPHENADRINE CITRATE | 100MG | tablet, extended release · oral | RISING | Prescription | 29 Jan 1999 |
| ORPHENADRINE CITRATE | 100MG | tablet, extended release · oral | SANDOZ | Prescription | 15 Feb 2000 |
| ORPHENADRINE CITRATE | 30MG/ML | injectable · injection | HIKMA PHARMS | Prescription | 4 Mar 2003 |
| ORPHENADRINE CITRATE | 30MG/ML | injectable · injection | RISING | Prescription | 24 May 2006 |
| ORPHENADRINE CITRATE | 30MG/ML | injectable · injection | SAGENT PHARMS | Prescription | 30 Aug 2011 |
| ORPHENADRINE CITRATE | 100MG | tablet, extended release · oral | UNICHEM | Prescription | 27 Jul 2012 |
| DISIPAL | 50MG | tablet · oral | 3M | Discontinued | 10 May 1957 |
| NORFLEX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet, extended release · oral | BAUSCH | Discontinued | 4 Nov 1959 |
| NORFLEX | 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · injection | PAI HOLDINGS PHARM | Discontinued | 2 Oct 1960 |
| ORPHENADRINE CITRATE | 30MG/ML | injectable · injection | WATSON LABS | Discontinued | 16 Jul 1981 |
| ORPHENADRINE CITRATE | 100MG | tablet, extended release · oral | STEVENS J | Discontinued | 23 Jun 2000 |
| ORPHENADRINE CITRATE | 100MG | tablet, extended release · oral | WATSON LABS | Discontinued | |
| ORPHENADRINE CITRATE | 100MG | tablet, extended release · oral | SANDOZ | Discontinued | |
| ORPHENADRINE CITRATE | 100MG | tablet, extended release · oral | ASCOT | Discontinued |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| SANDOZ ORPHENADRINE | 02243559 | 100 MG | TABLET (EXTENDED-RELEASE) · ORAL | SANDOZ CANADA INCORPORATED |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | ORPHENADRINE 60 MG/2 ML VIAL | $5.73029 | per ML | 23 Sep 2026 |
| US NADAC | ORPHENADRINE 60 MG/2 ML VIAL | $7.0744 | per ML | 22 Jul 2026 |
| US NADAC | ORPHENADRINE ER 100 MG TABLET | $0.45364 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Orphenadrine 50mg/5ml oral solution sugar free | £151.02 | 150 ml | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 28 Apr 2021 NORGESIC — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 28 Apr 2021 NORGESIC FORTE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Combinations containing Orphenadrine
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.