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Active ingredient

Orphenadrine

20 finished FDA listings contain Orphenadrine as their only active ingredient; 5 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
ORPHENADRINE CITRATE
Dosage forms
Injection, Injection, Solution, Tablet, Extended Release
Routes
Intramuscular, Intravenous, Oral
Manufacturers / labelers
17
Strengths listed
100 mg/1 · 30 mg/ml · 60 mg/2ml
Brand names in FDA listings
Orphenadrine Citrate Er

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 7715

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
ANDA 084779WATSON LABS1982-03-151
ANDA 040284LUPIN1998-06-1914
ANDA 040327SANDOZ2000-02-153
ANDA 040463HIKMA2003-03-041
ANDA 090585SAGENT PHARMS2011-08-301

Official labeling on DailyMed

Showing the 12 most recent of 20 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.