FDA.reportPublic FDA data

NDC 70518-4333-00 - 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
70518-4333
Requested NDC
70518-4333-00
Package NDCs from labels
70518-4333-0, 70518-4333-00
Manufacturer
REMEDYREPACK INC.
Effective date
2026-09-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Guanfacine Tablets, USP Rx onlyREMEDYREPACK INC.2026-09-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4333-0Guanfacine30 in 1 BLISTER PACKTABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4333GUANFACINE (GUANFACINE) TABLET [REMEDYREPACK INC.]1Current NDC, 1 package rows20250427_04a3bd2d-9a9c-43e8-a0e2-280e02265f16.zip

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 9 · 166 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meijer Effervescent Antacid and Pain ReliefASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEMeijer Distribution Inc7305972b-aa0f-4daa-e053-2991aa0adfd72026-05-11WarningsExact identifier
unii: XF417D3PSL
Guanfacine extended-releaseGUANFACINEApotex Corp.1c492e87-3406-ddb8-aaf2-e609c2ded5032026-05-06Warnings, Adverse reactionsExact identifier
unii: PML56A160O
GuanfacineGUANFACINEMajor Pharmaceuticals400be431-ad6c-4783-a513-ca8b47bf43ee2026-05-04Adverse reactionsExact identifier
rxcui: 197745
unii: PML56A160O
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
CLENPIQSODIUM PICOSULFATE, MAGNESIUM OXIDE, AND ANHYDROUS CITRIC ACIDFerring Pharmaceuticals Inc.e95fff66-4ec0-4001-a727-33e66a5ec7d52026-04-15Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
Guanfacine HydrochlorideGUANFACINEAmneal Pharmaceuticals of New York LLC73d50917-c807-4213-8efe-aea2098459362026-04-14Adverse reactionsExact identifier
rxcui: 197746
rxcui: 197745
unii: PML56A160O
Guanfacine HydrochlorideGUANFACINE HYDROCHLORIDEREMEDYREPACK INC.1b1063ba-fee3-4540-9139-db4b915f82e22026-04-10Adverse reactionsExact identifier
rxcui: 197746
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: XF417D3PSL
Leader Extra Strength Effervescent Antacid and Pain RelieverASPIRIN, CITRIC ACID, SODIUM BICARBONATECardinal Healthc5d7bf5f-3e59-52f2-e053-2a95a90a4a002026-02-25WarningsExact identifier
unii: XF417D3PSL
Guanfacine HydrochlorideGUANFACINEAvPAKcc3cc6de-583c-4180-9f4c-9e4c75eb6f382026-02-24Adverse reactionsExact identifier
rxcui: 197746
rxcui: 197745
unii: PML56A160O
GUANFACINEGUANFACINEGolden State Medical Supply, Inc.4b86e1c1-9cbe-d4a9-e063-6294a90a22742026-02-23Warnings, Adverse reactionsExact identifier
unii: PML56A160O
Mitochondria ProARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,Energique, Inc.2f365207-b730-428d-9465-8853e86e79ff2026-02-18WarningsExact identifier
unii: XF417D3PSL
Guanfacine extended-releaseGUANFACINEBryant Ranch Prepack1c5d9514-641a-4c72-a79a-96a0fe5d6fbd2026-02-13Warnings, Adverse reactionsExact identifier
unii: PML56A160O
Guanfacine extended-releaseGUANFACINEBryant Ranch Prepack07cda4a1-0eb5-491e-8d16-4e6a6feb93ac2026-02-10Warnings, Adverse reactionsExact identifier
unii: PML56A160O
GuanfacineGAUNFACINEREMEDYREPACK INC.46dcdeaa-ec2a-48d6-b315-fcc3dd71c5e02026-02-03Adverse reactionsExact identifier
rxcui: 197746
unii: PML56A160O
GuanfacineGUANFACINECoupler LLC4973deb3-57ec-1ef3-e063-6294a90aa0352026-01-28Adverse reactionsExact identifier
application number: ANDA217293
rxcui: 197746
unii: PML56A160O
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAtlantic Biologicals Corp.42d837ae-2578-46df-92d2-24774964aaad2026-01-28Adverse reactionsExact identifier
unii: XF417D3PSL
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
GuanfacineGUANFACINEREMEDYREPACK INC.145a191d-9049-4014-9c42-503fdde063dc2026-01-14Warnings, Adverse reactionsExact identifier
unii: PML56A160O

Reported adverse events (FAERS/openFDA)#

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