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Active ingredient

Clozapine

48 finished FDA listings contain Clozapine as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
CLOZAPINE
Dosage forms
Suspension, Tablet, Tablet, Orally Disintegrating
Routes
Oral
Manufacturers / labelers
13
Strengths listed
100 mg/1 · 12.5 mg/1 · 150 mg/1 · 200 mg/1 · 25 mg/1 · 50 mg/1 · 50 mg/ml
Brand names in FDA listings
Clozaril, Versacloz

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 2626

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 019758HERITAGE LIFE1989-09-262
ANDA 075417MYLAN1999-05-2710
NDA 203479DOUGLAS PHARMS2013-02-061
ANDA 201824MYLAN2015-09-156
ANDA 090308BARR LABS INC2015-11-255
ANDA 202873ACCORD HLTHCARE2015-11-252
ANDA 206433AUROBINDO PHARMA2016-11-2917
ANDA 212923AUROBINDO PHARMA2024-12-125

Official labeling on DailyMed

Showing the 12 most recent of 16 labels.

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