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Active ingredient

Primidone

44 finished FDA listings contain Primidone as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
PRIMIDONE
Dosage forms
Tablet
Routes
Oral
Manufacturers / labelers
22
Strengths listed
125 mg/1 · 250 mg/1 · 50 mg/1
Brand names in FDA listings
Mysoline

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 8691

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
NDA 009170VALEANT1954-03-082
ANDA 084903LANNETT1978-12-018
ANDA 083551WATSON LABS1979-02-071
ANDA 040586OXFORD PHARMS2005-02-2413
ANDA 040866AMNEAL PHARM2008-04-2310
ANDA 040862CHARTWELL RX2008-10-032
ANDA 214896RUBICON RESEARCH2022-06-286
ANDA 218366CARNEGIE2024-01-232

Official labeling on DailyMed

Showing the 12 most recent of 27 labels.

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