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Active ingredient

Misoprostol

26 finished FDA listings contain Misoprostol as their only active ingredient; 26 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
MISOPROSTOL
Dosage forms
Liquid, Tablet
Routes
Oral, Topical
Manufacturers / labelers
17
Strengths listed
10 g/100ml · 100 ug/1 · 200 ug/1
Brand names in FDA listings
Cytotec, Tobcharm Toenail Fungus Treatment Liquid

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 42331

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 019268PFIZER1988-12-276
ANDA 076095ANI PHARMS2002-07-1010
ANDA 091667NOVEL LABS INC2012-07-256
ANDA 210201ACQ PHARMA2019-07-023

Official labeling on DailyMed

Showing the 12 most recent of 19 labels.

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