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Active ingredient

Propofol

38 finished FDA listings contain Propofol as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
PROPOFOL
Dosage forms
Injection, Emulsion
Routes
Intravenous
Manufacturers / labelers
14
Strengths listed
10 mg/ml
Brand names in FDA listings
Diprivan

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 8782

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 019627FRESENIUS KABI USA1989-10-025
ANDA 075102SAGENT PHARMS INC1999-01-041
ANDA 074848HIKMA2005-04-193
ANDA 077908HOSPIRA2006-03-178
ANDA 205067DR REDDYS2018-11-153
ANDA 205576INNOPHARMA2020-09-166
ANDA 206408AVET LIFESCIENCES2021-10-125
ANDA 217525AMNEAL2024-08-153
ANDA 217945EMERGE BIOSCIENCE2025-12-023
ANDA 220857ADAPTIS2026-07-141

Official labeling on DailyMed

Showing the 12 most recent of 17 labels.

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