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Active ingredient

Hydroxychloroquine

57 finished FDA listings contain Hydroxychloroquine as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
HYDROXYCHLOROQUINE SULFATE
Dosage forms
Tablet, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
31
Strengths listed
100 mg/1 · 200 mg/1 · 300 mg/1 · 400 mg/1
Brand names in FDA listings
Plaquenil, Sovuna

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 5521

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 009768ADVANZ PHARMA1955-04-183
ANDA 040081TEVA PHARMS1994-09-302
ANDA 040150CREEKWOOD PHARMS1996-01-276
ANDA 040274AUROBINDO PHARMA USA1998-05-291
ANDA 040766IPCA LABS LTD2007-06-143
ANDA 040657ZYDUS PHARMS USA INC2007-09-2117
ANDA 210441APPCO2018-05-019
ANDA 201691ALKALOIDA ZRT2018-05-081
ANDA 210577AMNEAL PHARMS CO2018-05-155
ANDA 210543CHARTWELL RX2018-07-061
ANDA 210959LAURUS2019-01-152
ANDA 213342ACCORD HLTHCARE2020-04-075
NDA 214581NOVITIUM PHARMA2022-01-142

Official labeling on DailyMed

Showing the 12 most recent of 50 labels.

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