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Active ingredient

Clonazepam

144 finished FDA listings contain Clonazepam as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
CLONAZEPAM
Dosage forms
Tablet, Tablet, Orally Disintegrating
Routes
Oral
Manufacturers / labelers
32
Strengths listed
.125 mg/1 · .25 mg/1 · .5 mg/1 · 1 mg/1 · 2 mg/1
Brand names in FDA listings
Klonopin

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 2598

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 017533CHEPLAPHARM1975-06-043
ANDA 074569TEVA1996-09-1012
ANDA 074925CHARTWELL RX1997-09-303
ANDA 075150AUROBINDO PHARMA USA1998-10-0512
ANDA 075468RUBICON RESEARCH2000-10-0621
ANDA 077147ACCORD HLTHCARE2005-05-0226
ANDA 077171PH HEALTH2005-08-035
ANDA 077194BARR2005-08-105
ANDA 077856PRINSTON INC2006-06-2842
ANDA 211033ALEMBIC2019-06-2810
ANDA 216988RUBICON RESEARCH2026-05-215

Official labeling on DailyMed

Showing the 12 most recent of 95 labels.

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