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Active ingredient

Phenobarbital

184 finished FDA listings contain Phenobarbital as their only active ingredient; 11 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
PHENOBARBITAL, PHENOBARBITAL SODIUM
Dosage forms
Elixir, Injection, Injection, Solution, Liquid, Solution, Tablet
Routes
Intramuscular, Intravenous, Oral
Manufacturers / labelers
29
Strengths listed
100 mg/1 · 130 mg/ml · 15 mg/1 · 16.2 mg/1 · 20 mg/5ml · 30 mg/1 · 30 mg/7.5ml · 32.4 mg/1 · 60 mg/1 · 60 mg/15ml · 64.8 mg/1 · 65 mg/ml · 97.2 mg/1
Brand names in FDA listings
Phenobarbital Oral Solution, Sezaby

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 8134

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 215910SUN PHARM INDS INC2022-11-171

Official labeling on DailyMed

Showing the 12 most recent of 83 labels.

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