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Active ingredient

Hydroxyurea

21 finished FDA listings contain Hydroxyurea as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
HYDROXYUREA
Dosage forms
Capsule, Solution, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
14
Strengths listed
100 mg/1 · 100 mg/ml · 1000 mg/1 · 200 mg/1 · 300 mg/1 · 400 mg/1 · 500 mg/1
Brand names in FDA listings
Droxia, Hydrea, Siklos, Xromi

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 5552

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 016295WAYLIS THERAP1967-12-078
ANDA 075143BARR1998-10-162
ANDA 075340PH HEALTH1999-02-243
NDA 208843THERAVIA2017-12-212
ANDA 213438LEADING2020-04-082
ANDA 218021QILU2024-03-063
NDA 216593NOVA LABS LTD2024-04-041

Official labeling on DailyMed

Showing the 12 most recent of 16 labels.

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