Orphenadrine Citrate

Sold as Norflex. Every FDA application for this active ingredient: 2 branded and 13 generic.

As of Nov 15, 2026, FDA lists 15 applications for Orphenadrine Citrate (sold as Norflex), first approved Nov 4, 1959, with 0 new uses approved and 0 published complete response letters.

First approved: Nov 4, 1959
Applications: 15
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $2.3M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Orphenadrine Citrate ER	Part D	$2.0M	-3%	40,191
Orphenadrine Citrate	Part D	$197K	-17%	2,696
Orphenadrine Citrate	Part B	$46K	-10%	2,690

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

ORPHENADRINE 60 MG/2 ML VIAL: $5.73 per MLGeneric · -1% in a year
ORPHENADRINE ER 100 MG TABLET: $0.480 per unitGeneric · +10% in a year

Clinical Trials

2 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Effectiveness of Chlorzoxazone Versus Orphenadrine Citrate in Alleviating Bruxism PainOrofacial Pain, Bruxism · University of Baghdad	Phase 4	Recruiting	Aug 7, 2025
Study of Orphenadrine' in the Treatment of Muscle Cramps in Patients With CirrhosisLiver Cirrhosis, Muscle Cramps · Sherief Abd-Elsalam	Phase 3	Recruiting	Apr 22, 2015

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Nov 4, 1959	NorflexNDA 12157 · New active ingredient	Bausch	11	Discontinued
Oct 2, 1960	NorflexNDA 13055 · New dosage form	Pai Holdings Pharm	10	Discontinued
Jul 16, 1981	Orphenadrine CitrateANDA 87062	Watson Labs	16	Discontinued
Mar 15, 1982	Orphenadrine CitrateANDA 84779	Watson Labs	13	Marketed
Jun 19, 1998	Orphenadrine CitrateANDA 40284	Lupin	12	Marketed
Jan 29, 1999	Orphenadrine CitrateANDA 40249	Rising	1	Marketed
Feb 15, 2000	Orphenadrine CitrateANDA 40327	Sandoz	4	Marketed
Jun 23, 2000	Orphenadrine CitrateANDA 40368	Stevens J	3	Discontinued
Mar 4, 2003	Orphenadrine CitrateANDA 40463	Hikma	2	Marketed
May 24, 2006	Orphenadrine CitrateANDA 40484	Rising	0	Marketed
Aug 30, 2011	Orphenadrine CitrateANDA 90585	Sagent Pharms	0	Marketed
Jul 27, 2012	Orphenadrine CitrateANDA 91158	Unichem	0	Marketed
—	Orphenadrine CitrateANDA 84303	Watson Labs	0	Discontinued
—	Orphenadrine CitrateANDA 85046	Sandoz	5	Discontinued
—	Orphenadrine CitrateANDA 88067	Ascot	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA