FDA.reportPublic FDA data

NDC 70518-4675-00 - Guanfacine

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
70518-4675
Requested NDC
70518-4675-00
Package NDCs from labels
70518-4675-0, 70518-4675-00
Manufacturer
REMEDYREPACK INC.
Effective date
2026-08-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Guanfacine - REMEDYREPACK INC.REMEDYREPACK INC.2026-08-03HUMAN PRESCRIPTION DRUG LABEL

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 7 · 124 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Guanfacine extended-releaseGUANFACINEApotex Corp.1c492e87-3406-ddb8-aaf2-e609c2ded5032026-05-06Warnings, Adverse reactionsExact identifier
rxcui: 862013
rxcui: 862025
rxcui: 862006
rxcui: 862019
unii: PML56A160O
GuanfacineGUANFACINEMajor Pharmaceuticals400be431-ad6c-4783-a513-ca8b47bf43ee2026-05-04Adverse reactionsExact identifier
unii: PML56A160O
Diathesis IIIHEART (SUIS), SMALL INTESTINE (SUIS), GERMANIUM SESQUIOXIDE, COBALTUM METALLICUM, CYSTEINUM, MANGANUM METALLICUM, MANGANESE GLUCONATE, ALPHA-KETOGLUTARICUM ACIDUM, ARSENICUM ALBUM, AURUM METALLICUM, FUMARICUM ACIDUM, NATRUM OXALACETICUM, PHOSPHORUSBioActive Nutritional, Inc.d914f6d6-5008-4153-81d3-87a297ac5d202026-04-27WarningsExact identifier
unii: 88XHZ13131
Guanfacine HydrochlorideGUANFACINEAmneal Pharmaceuticals of New York LLC73d50917-c807-4213-8efe-aea2098459362026-04-14Adverse reactionsExact identifier
unii: PML56A160O
Refresh Optive Mega-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
unii: 6OZP39ZG8H
911 Adrenal Burnout and FatigueACETICUM AC, ADRENALINUM, ADRENOCORTICOTROPHIN (30X), AESCULUS HIPPOCASTANUM, FLOS, ALFALFA, ALPHA-LIPOIC AC, AMBRA, ARG NIT, AVENA SATIVA, BRYONIA, CARBONEUM OXYGENISATUM, CARPINUS BETULUS, FLOS, DNA, FUMARICUM ACIDUM, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, HYPOTHALAMUS, KALI PHOSPHORICUM, LACTICUM ACIDUM, LECITHIN, NATRUM MURIATICUM, OXALICUM ACIDUM, PHOSPHORICUM ACIDUM, PITUITARUM POSTERIUM, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SEPIA, SILICEA, SUCCINICUM ACIDUM AND THYROIDINUM.King Bio Inc.21c6b6c1-e846-4f25-a1dc-02e79d1be7562026-02-26WarningsExact identifier
unii: 88XHZ13131
Kidnex IVGINKGO BILOBA, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALICUM ACIDUM, PYRUVIC ACID, SUCCINICUM ACIDUM, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, GERMANIUM SESQUIOXIDE, MERCURIUS VIVUS, NUX VOMICA, KIDNEY (SUIS), LYMPH NODE (SUIS), NAPHTHOCHINONUM, NATRUM OXALACETICUM, PHOSPHORUS, URINARY BLADDER (SUIS), ACONITICUM ACIDUM, CIS-Energique, Inc.23de6b8e-7622-4ba6-89f7-37bd151687e22026-02-26WarningsExact identifier
unii: 88XHZ13131
Guanfacine HydrochlorideGUANFACINEAvPAKcc3cc6de-583c-4180-9f4c-9e4c75eb6f382026-02-24Adverse reactionsExact identifier
unii: PML56A160O
GUANFACINEGUANFACINEGolden State Medical Supply, Inc.4b86e1c1-9cbe-d4a9-e063-6294a90a22742026-02-23Warnings, Adverse reactionsExact identifier
rxcui: 862013
rxcui: 862025
rxcui: 862006
rxcui: 862019
unii: PML56A160O
Guanfacine extended-releaseGUANFACINEBryant Ranch Prepack1c5d9514-641a-4c72-a79a-96a0fe5d6fbd2026-02-13Warnings, Adverse reactionsExact identifier
rxcui: 862006
unii: PML56A160O
Guanfacine extended-releaseGUANFACINEBryant Ranch Prepack07cda4a1-0eb5-491e-8d16-4e6a6feb93ac2026-02-10Warnings, Adverse reactionsExact identifier
rxcui: 862013
unii: PML56A160O
GuanfacineGAUNFACINEREMEDYREPACK INC.46dcdeaa-ec2a-48d6-b315-fcc3dd71c5e02026-02-03Adverse reactionsExact identifier
unii: PML56A160O
GuanfacineGUANFACINECoupler LLC4973deb3-57ec-1ef3-e063-6294a90aa0352026-01-28Adverse reactionsExact identifier
unii: PML56A160O
GuanfacineGUANFACINEREMEDYREPACK INC.145a191d-9049-4014-9c42-503fdde063dc2026-01-14Warnings, Adverse reactionsExact identifier
application number: ANDA219033
rxcui: 862006
unii: PML56A160O
Causticum Combination 9253CAUSTICUM COMBINATIONProfessional Complementary Health Formulas82b1a723-63e6-41b4-9940-a984dd719c872026-01-08WarningsExact identifier
unii: 88XHZ13131
Arsenicum Combination 9251ARSENICUM COMBINATIONProfessional Complementary Health Formulasc52598b3-7100-4410-a4cb-b3dcacf445d72026-01-08WarningsExact identifier
unii: 88XHZ13131
GuanfacineGUANFACINECoupler LLC266c6819-cd71-55d0-e063-6394a90ab1572026-01-08Adverse reactionsExact identifier
unii: PML56A160O
Thyroid Nosode Combination 9420THYROID NOSODE COMBINATIONProfessional Complementary Health Formulasf107e47e-4176-411f-83ac-bb2d0096b3b32026-01-08WarningsExact identifier
unii: 88XHZ13131
Selenium Combination 9245SELENIUM COMBINATIONProfessional Complementary Health Formulas1c2cc0ad-f859-470b-be4b-f98e010a2e5c2026-01-08WarningsExact identifier
unii: 88XHZ13131
GuanfacineGUANFACINEAdvagen Pharma Ltd87e1ad56-a7b9-431d-a5d2-d52fb64735c72025-12-31Adverse reactionsExact identifier
unii: PML56A160O

Reported adverse events (FAERS/openFDA)#

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