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Active ingredient

Ketamine

28 finished FDA listings contain Ketamine as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
KETAMINE HYDROCHLORIDE
Dosage forms
Injection, Injection, Solution, Injection, Solution, Concentrate
Routes
Intramuscular, Intravenous
Manufacturers / labelers
12
Strengths listed
10 mg/ml · 100 mg/ml · 50 mg/ml
Brand names in FDA listings
Ketalar

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 6130

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 016812PH HEALTH1970-02-194
ANDA 074524HIKMA1996-03-225
ANDA 074549HOSPIRA1996-06-274
ANDA 076092EUGIA PHARMA2001-12-283
ANDA 215808FRESENIUS KABI USA2023-01-135
ANDA 216809GLAND2023-01-246
ANDA 219684BAXTER HLTHCARE CORP2025-09-171

Official labeling on DailyMed

Showing the 12 most recent of 15 labels.

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