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Active ingredient

Alprazolam

139 finished FDA listings contain Alprazolam as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
ALPRAZOLAM
Dosage forms
Solution, Concentrate, Tablet, Tablet, Extended Release, Tablet, Orally Disintegrating
Routes
Oral
Manufacturers / labelers
33
Strengths listed
.25 mg/1 · .5 mg/1 · 1 mg/1 · 1 mg/ml · 2 mg/1 · 3 mg/1
Brand names in FDA listings
Alprazolam Extended Release, Alprazolam Xr, Xanax, Xanax Xr

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 596

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 018276UPJOHN1981-10-1622
ANDA 074174NOVITIUM PHARMA1993-10-194
ANDA 074312HIKMA1993-10-311
ANDA 074342ACTAVIS ELIZABETH1993-10-3115
ANDA 074112SANDOZ1995-12-2914
ANDA 074909SANDOZ1998-03-255
NDA 021434UPJOHN2003-01-176
ANDA 078056ACTAVIS ELIZABETH2007-02-132
ANDA 078387AMNEAL PHARMS NY2008-05-304
ANDA 078088PH HEALTH2009-01-095
ANDA 078561ACTAVIS ELIZABETH2010-03-164
ANDA 090871AUROBINDO PHARMA2011-06-0712
ANDA 200739NATCO2015-04-154
ANDA 203346AUROBINDO PHARMA2015-07-3141

Official labeling on DailyMed

Showing the 12 most recent of 79 labels.

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