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Active ingredient

Guanfacine

122 finished FDA listings contain Guanfacine as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
GUANFACINE, GUANFACINE HYDROCHLORIDE
Dosage forms
Tablet, Tablet, Extended Release
Routes
Oral
Manufacturers / labelers
38
Strengths listed
1 mg/1 · 2 mg/1 · 3 mg/1 · 4 mg/1
Brand names in FDA listings
Guanfacine, Guanfacine Extended-Release, Guanfacine Hydrochloride, Intuniv

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 40114

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 074145WATSON LABS1995-10-172
ANDA 074796AUROBINDO PHARMA USA1997-01-272
ANDA 074673EPIC PHARMA LLC1997-02-285
ANDA 075109AMNEAL PHARM1998-11-257
NDA 022037TAKEDA PHARMS USA2009-09-024
ANDA 200881ACTAVIS ELIZABETH2012-10-054
ANDA 201408TWI PHARMS2015-06-0214
ANDA 205689SUN PHARM2017-11-1613
ANDA 205430APOTEX2018-07-2511
ANDA 213428YICHANG HUMANWELL2020-11-255
ANDA 214689UNICHEM2021-03-034
ANDA 216399AIPING PHARM INC2022-06-084
ANDA 217293AJANTA PHARMA LTD2023-04-276
ANDA 217269ALEMBIC2023-08-0716
ANDA 216828PHARMAZONE2023-10-055
ANDA 216762RUBICON RESEARCH2023-10-172
ANDA 218326XIROMED2024-02-234
ANDA 217638FOSUN WANBANG2024-06-124
ANDA 219033UNICHEM2024-11-196
ANDA 219689RUBICON RESEARCH2025-04-154

Official labeling on DailyMed

Showing the 12 most recent of 62 labels.

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