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Active ingredient

Amantadine

61 finished FDA listings contain Amantadine as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
AMANTADINE, AMANTADINE HYDROCHLORIDE, AMANTADINE SULFATE
Dosage forms
Capsule, Capsule, Coated Pellets, Capsule, Gelatin Coated, Capsule, Liquid Filled, Solution, Tablet
Routes
Oral
Manufacturers / labelers
36
Strengths listed
100 mg/1 · 100 mg/10ml · 137 mg/1 · 50 mg/5ml · 68.5 mg/1
Brand names in FDA listings
Amantadine Hcl, Gocovri

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 620

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
ANDA 070589UPSHER SMITH LABS1987-01-071
ANDA 071293SANDOZ1987-02-181
ANDA 074028CHARTWELL RX1993-06-283
ANDA 074509PHARM ASSOC1995-07-174
ANDA 075060PHARMOBEDIENT1998-12-242
ANDA 075819ADAPTIS2002-09-111
ANDA 076186UPSHER SMITH LABS2002-12-161
ANDA 078720BIONPHARMA2008-05-293
ANDA 208278ZYDUS PHARMS2016-05-316
ANDA 209047STRIDES PHARMA2017-06-074
ANDA 209035STRIDES PHARMA2017-06-093
ANDA 209171HERITAGE PHARMA2017-06-128
ANDA 208966ALEMBIC2017-06-213
NDA 208944SUPERNUS PHARMS2017-08-244
ANDA 210129RISING2020-03-023
ANDA 210215PHARMOBEDIENT2020-03-101
ANDA 212044RUBICON RESEARCH2020-05-214
ANDA 214284ALEMBIC2020-10-155
ANDA 214178PHARMOBEDIENT2021-08-201
ANDA 211354ONESOURCE2022-02-181
ANDA 214580HUMANWELL PURACAP2022-12-201
ANDA 218598ZHEJIANG JUTAI PHARM2024-09-261

Official labeling on DailyMed

Showing the 12 most recent of 57 labels.

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