FDA.reportPublic FDA data

guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet

RxCUI
862013
RxNorm name
guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet
Display name
guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet
Full name
guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:46

RxNav Current And Historical NDCs#

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UNII Substances#

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openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Guanfacine Extended-ReleaseGUANFACINEProficient Rx LP6460ad33-4feb-4a4d-9958-5010840463892022-04-01Warnings, Adverse reactionsExact identifier
rxcui: 862013
guanfacineGUANFACINEActavis Pharma, Inc.3a171942-37af-430d-8b9d-bb678ca2be4b2020-01-31Warnings, Adverse reactionsExact identifier
rxcui: 862013

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 24 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
07cda4a1-0eb5-491e-8d16-4e6a6feb93acguanFACINE 2 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR guanfacine 2 MG Extended Release Oral Tablet [SCD] · guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet [SY] · guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet [SY]4103These highlights do not include all the information needed to use GUANFACINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GUANFACINE EXTENDED-RELEASE TABLETS . GUANFACINE Extended-Release tablets, for oral use Initial U.S. Approval: 198620260210
6e16cf54-c0d7-47ea-b502-c2146fd87f23guanFACINE 2 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR guanfacine 2 MG Extended Release Oral Tablet [SCD] · guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet [SY] · guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet [SY]4102HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use GUANFACINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GUANFACINE EXTENDED-RELEASE TABLETS. GUANFACINE extended-release tablets, for oral use Initial U.S. Approval: 198620250204
ba58a5d0-607b-4dca-a63e-92d8dd81d81bguanFACINE 2 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR guanfacine 2 MG Extended Release Oral Tablet [SCD] · guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet [SY] · guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet [SY]4102HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use GUANFACINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GUANFACINE EXTENDED-RELEASE TABLETS. GUANFACINE extended-release tablets, for oral use Initial U.S. Approval: 198620250124
178b649f-8c0f-4fea-a168-3ce4ff52129dguanFACINE 2 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR guanfacine 2 MG Extended Release Oral Tablet [SCD] · guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet [SY] · guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet [SY]4100These highlights do not include all the information needed to use GUANFACINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GUANFACINE EXTENDED-RELEASE TABLETS . GUANFACINE Extended-Release tablets, for oral use Initial U.S. Approval: 198620251030
b972af81-3a37-40be-9fe1-3ddf59852528guanFACINE 2 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR guanfacine 2 MG Extended Release Oral Tablet [SCD] · guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet [SY] · guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet [SY]444These highlights do not include all the information needed to use INTUNIV ® safely and effectively. See full prescribing information for INTUNIV. INTUNIV ® (guanfacine) extended-release tablets, for oral use Initial U.S. Approval: 198620250623
3a171942-37af-430d-8b9d-bb678ca2be4bguanFACINE 2 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR guanfacine 2 MG Extended Release Oral Tablet [SCD] · guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet [SY] · guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet [SY]422These highlights do not include all the information needed to use GUANFACINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GUANFACINE EXTENDED-RELEAS E TABLETS . GUANFACINE extended-release tablets, for oral use Initial U.S. Approval: 198620200101
ed65ca51-b9b0-43b9-9826-03a7be256a2aguanFACINE 2 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR guanfacine 2 MG Extended Release Oral Tablet [SCD] · guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet [SY] · guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet [SY]418These highlights do not include all the information needed to use GUANFACINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GUANFACINE EXTENDED-RELEASE TABLETS. GUANFACINE extended-release tablets, for oral use Initial U.S. Approval: 198620251201
07a701e2-39b7-4bb1-a7c7-d9baed4ab18aguanFACINE 2 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR guanfacine 2 MG Extended Release Oral Tablet [SCD] · guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet [SY] · guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet [SY]415These highlights do not include all the information needed to use GUANFACINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GUANFACINE EXTENDED-RELEASE TABLETS. GUANFACINE extended-release tablets, for oral use Initial U.S. Approval: 198620250429
2d0a0f8e-5098-4ee2-a4ee-d026789923e2guanFACINE 2 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR guanfacine 2 MG Extended Release Oral Tablet [SCD] · guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet [SY] · guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet [SY]414HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use GUANFACINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GUANFACINE EXTENDED-RELEASE TABLETS. GUANFACINE extended-release tablets, for oral use Initial U.S. Approval: 198620241227
6006df06-0448-462d-b81e-7add50a6d71bguanFACINE 2 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR guanfacine 2 MG Extended Release Oral Tablet [SCD] · guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet [SY] · guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet [SY]412GUANFACINE EXTENDED-RELEASE TABLETS. These highlights do not include all the information needed to use GUANFACINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GUANFACINE EXTENDED-RELEASE TABLETS. GUANFACINE extended-release tablets, for oral use Initial U.S. Approval: 198620260527
1c492e87-3406-ddb8-aaf2-e609c2ded503guanFACINE 2 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR guanfacine 2 MG Extended Release Oral Tablet [SCD] · guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet [SY] · guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet [SY]412These highlights do not include all the information needed to use GUANFACINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GUANFACINE EXTENDED-RELEASE TABLETS . GUANFACINE Extended-Release tablets, for oral use Initial U.S. Approval: 198620260506
301f01a7-2b0a-cfba-9c3d-a1dd831785a3guanFACINE 2 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR guanfacine 2 MG Extended Release Oral Tablet [SCD] · guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet [SY] · guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet [SY]49Guanfacine Extended-Release Tablets Rx Only These highlights do not include all the information needed to use GUANFACINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GUANFACINE EXTENDED-RELEAS E TABLETS . GUANFACINE extended-release tablets, for oral use Initial U.S. Approval: 198620251111
3ec4fed6-cafc-49a0-9540-8d70ac435769guanFACINE 2 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR guanfacine 2 MG Extended Release Oral Tablet [SCD] · guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet [SY] · guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet [SY]47These highlights do not include all the information needed to use GUANFACINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GUANFACINE EXTENDED-RELEASE TABLETS. GUANFACINE extended-release tablets, for oral use Initial U.S. Approval: 198620251028
f4e3c976-8811-4388-92b3-d248d705f8b1guanFACINE 2 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR guanfacine 2 MG Extended Release Oral Tablet [SCD] · guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet [SY] · guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet [SY]46These highlights do not include all the information needed to use GUANFACINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GUANFACINE EXTENDED-RELEASE TABLETS. GUANFACINE extended-release tablets, for oral use Initial U.S. Approval: 198620250722
8348e63a-5cbc-489e-b7bf-046c65ba2e8eguanFACINE 2 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR guanfacine 2 MG Extended Release Oral Tablet [SCD] · guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet [SY] · guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet [SY]44These highlights do not include all the information needed to use GUANFACINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GUANFACINE EXTENDED-RELEASE TABLETS . GUANFACINE Extended-Release tablets, for oral use Initial U.S. Approval: 198620250930
9db7def2-c6f9-4d7d-a403-fc615358913aguanFACINE 2 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR guanfacine 2 MG Extended Release Oral Tablet [SCD] · guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet [SY] · guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet [SY]44These highlights do not include all the information needed to use GUANFACINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GUANFACINE EXTENDED-RELEASE TABLETS. GUANFACINE extended-release tablets, for oral use Initial U.S. Approval: 198620250521
0b2afdab-8c92-463e-9734-f2c8b4200777guanFACINE 2 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR guanfacine 2 MG Extended Release Oral Tablet [SCD] · guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet [SY] · guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet [SY]44These highlights do not include all the information needed to use GUANFACINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GUANFACINE EXTENDED-RELEASE TABLETS. GUANFACINE extended-release tablets, for oral use Initial U.S. Approval: 198620241227
1bb3fac5-11e8-4d1c-a5e4-2520abcdeb47guanFACINE 2 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR guanfacine 2 MG Extended Release Oral Tablet [SCD] · guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet [SY] · guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet [SY]44These highlights do not include all the information needed to use INTUNIV safely and effectively. See full prescribing information for INTUNIV . INTUNIV (guanfacine) extended-release tablets, for oral use Initial U.S. Approval: 1986 ® ® ®20130831
e16beec7-9acd-4cd1-be5c-b666ad7d2430guanFACINE 2 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR guanfacine 2 MG Extended Release Oral Tablet [SCD] · guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet [SY] · guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet [SY]43These highlights do not include all the information needed to use GUANFACINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GUANFACINE EXTENDED-RELEASE TABLETS. GUANFACINE extended-release tablets, for oral use Initial U.S. Approval: 198620250424
6460ad33-4feb-4a4d-9958-501084046389guanFACINE 2 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR guanfacine 2 MG Extended Release Oral Tablet [SCD] · guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet [SY] · guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet [SY]42These highlights do not include all the information needed to use GUANFACINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GUANFACINE EXTENDED-RELEASE TABLETS. GUANFACINE extended-release tablets, for oral use Initial U.S. Approval: 198620220401
4b86e1c1-9cbe-d4a9-e063-6294a90a2274guanFACINE 2 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR guanfacine 2 MG Extended Release Oral Tablet [SCD] · guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet [SY] · guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet [SY]41GUANFACINE EXTENDED-RELEASE TABLETS. These highlights do not include all the information needed to use GUANFACINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GUANFACINE EXTENDED-RELEASE TABLETS. GUANFACINE extended-release tablets, for oral use Initial U.S. Approval: 198620260223
29f1eef1-bb81-3890-e063-6394a90ac8e7guanFACINE 2 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR guanfacine 2 MG Extended Release Oral Tablet [SCD] · guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet [SY] · guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet [SY]41These highlights do not include all the information needed to use GUANFACINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GUANFACINE EXTENDED-RELEASE TABLETS. GUANFACINE extended-release tablets, for oral use Initial U.S. Approval: 198620241223
261c06ce-8708-d659-e063-6294a90ac381guanFACINE 2 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR guanfacine 2 MG Extended Release Oral Tablet [SCD] · guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet [SY] · guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet [SY]41These highlights do not include all the information needed to use GUANFACINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GUANFACINE EXTENDED-RELEASE TABLETS. GUANFACINE extended-release tablets, for oral use Initial U.S. Approval: 198620241104
983b3157-cbea-435d-ba32-9ee7ef95226aguanFACINE 2 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR guanfacine 2 MG Extended Release Oral Tablet [SCD] · guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet [SY] · guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet [SY]41These highlights do not include all the information needed to use GUANFACINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GUANFACINE EXTENDED-RELEASE TABLETS. GUANFACINE extended-release tablets, for oral use Initial U.S. Approval: 198620230810