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Active ingredient

Zolpidem

146 finished FDA listings contain Zolpidem as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
ZOLPIDEM TARTRATE
Dosage forms
Capsule, Tablet, Tablet, Coated, Tablet, Extended Release, Tablet, Film Coated, Tablet, Film Coated, Extended Release
Routes
Oral, Sublingual
Manufacturers / labelers
45
Strengths listed
1.75 mg/1 · 10 mg/1 · 12.5 mg/1 · 3.5 mg/1 · 5 mg/1 · 6.25 mg/1 · 7.5 mg/1
Brand names in FDA listings
Ambien, Ambien Cr, Edluar, Zolpidem

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 39993

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 019908COSETTE1992-12-164
NDA 021774COSETTE2005-09-026
ANDA 077214PHARMAZONE2007-04-2324
ANDA 076410TEVA2007-04-232
ANDA 077322SANDOZ2007-04-2311
ANDA 078413AUROBINDO PHARMA2007-05-0424
ANDA 077903TORRENT PHARMS2007-08-1733
NDA 021997VIATRIS2009-03-132
ANDA 090107SANDOZ2011-07-015
ANDA 077388CHARTWELL MOLECULAR2012-07-302
ANDA 078970LUPIN2013-09-1115
ANDA 204299NOVEL LABS INC2015-06-032
ANDA 204170SUN PHARM2017-01-247
ANDA 204229PH HEALTH2017-09-112
ANDA 213592BRECKENRIDGE2020-06-044
NDA 215721ALMATICA2023-05-091
ANDA 220717UMEDICA LABS PVT2026-05-122

Official labeling on DailyMed

Showing the 12 most recent of 117 labels.

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