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Active ingredient

Memantine

121 finished FDA listings contain Memantine as their only active ingredient; 14 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
MEMANTINE, MEMANTINE HYDROCHLORIDE
Dosage forms
Capsule, Extended Release, Solution, Tablet, Tablet, Coated, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
39
Strengths listed
10 mg/1 · 14 mg/1 · 2 mg/ml · 21 mg/1 · 28 mg/1 · 5 mg/1 · 7 mg/1
Brand names in FDA listings
Memantine, Memantine Hydrochloride

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 6719

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 021487ABBVIE2003-10-165
ANDA 090048DR REDDYS LABS LTD2010-04-1412
ANDA 090058SUN PHARM2010-05-053
ANDA 090041AMNEAL PHARMS2015-04-104
ANDA 090051LUPIN2015-04-102
ANDA 090043UPSHER SMITH LABS2015-07-312
ANDA 202840MACLEODS PHARMS LTD2015-10-133
ANDA 202790MACLEODS PHARMS2015-10-131
ANDA 200022UNICHEM2015-10-137
ANDA 204033CHARTWELL MOLECULAR2015-10-132
ANDA 203175AUROBINDO PHARMA LTD2015-10-132
ANDA 200891ALEMBIC2015-10-134
ANDA 206528AJANTA PHARMA LTD2015-11-307
ANDA 206032RISING2016-09-284
ANDA 206028LUPIN2016-09-286
ANDA 205825AMNEAL PHARMS2016-10-124
ANDA 090961ZYDUS LIFESCIENCES2017-07-1018
ANDA 203293ZYDUS PHARMS2017-08-038
ANDA 209955APOTEX2018-02-091
ANDA 090244CHARTWELL2018-07-112
ANDA 212947YILING2020-04-032
ANDA 210319MEDLEY PHARMS2020-08-311
ANDA 211100YICHANG HUMANWELL2021-04-024
ANDA 214651AUROBINDO PHARMA LTD2021-08-095
ANDA 204389HETERO LABS LTD V2022-09-264
ANDA 213985H2-PHARMA2022-10-114
ANDA 206310MACLEODS PHARMS2025-08-284

Official labeling on DailyMed

Showing the 12 most recent of 68 labels.

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