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Active ingredient

Escitalopram

155 finished FDA listings contain Escitalopram as their only active ingredient.

FDA NDC Directory

Ingredient names as written by FDA
ESCITALOPRAM OXALATE
Dosage forms
Capsule, Solution, Tablet, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
46
Strengths listed
10 mg/1 · 10 mg/21 · 15 mg/1 · 20 mg/1 · 20 mg/21 · 5 mg/1 · 5 mg/5ml
Brand names in FDA listings
Escitalopram, Escitalopram Oral Solution, Escitalopram Oxalate, Lexapro

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 321988

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 021323ABBVIE2002-08-143
ANDA 202227AMNEAL PHARMS2012-03-141
ANDA 079062AUROBINDO PHARMA LTD2012-04-022
ANDA 079121SUN PHARMA CANADA2012-05-031
ANDA 202221HETERO LABS LTD III2012-06-121
ANDA 078604INVAGEN PHARMS2012-09-1111
ANDA 202210MACLEODS PHARMS LTD2012-09-118
ANDA 078169CHARTWELL RX2012-09-111
ANDA 090939TORRENT PHARMS LTD2012-09-1123
ANDA 090432AUROBINDO PHARMA LTD2012-09-1121
ANDA 202389ACCORD HLTHCARE2012-09-1118
ANDA 078777GRAVITI PHARMS2012-09-1116
ANDA 202280JUBILANT CADISTA2012-09-123
ANDA 090477CHARTWELL MOLECULAR2013-06-122
ANDA 078032PRINSTON INC2015-08-2833
ANDA 202754MACLEODS PHARMS LTD2016-03-311
ANDA 205619AMNEAL PHARMS2017-05-176
ANDA 215177ASCENT PHARMS INC2025-07-153
NDA 219130ALMATICA2025-08-291

Official labeling on DailyMed

Showing the 12 most recent of 114 labels.

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