FDA.reportPublic FDA data

NDC 70518-4564-00 - 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
70518-4564
Requested NDC
70518-4564-00
Package NDCs from labels
70518-4564-0, 70518-4564-00
Manufacturer
REMEDYREPACK INC.
Effective date
2026-02-03
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.2026-02-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4564-0Guanfacine30 in 1 BLISTER PACKTABLET301

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 4 · 62 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GuanfacineGAUNFACINEREMEDYREPACK INC.46dcdeaa-ec2a-48d6-b315-fcc3dd71c5e02026-02-03Adverse reactionsExact identifier
application number: ANDA216828
ndc (package): 70518-4564-0
ndc (product): 70518-4564
ndc11 (package): 70518456400
rxcui: 197746
spl id: 49ee625b-ae00-dde3-e063-6294a90a87e8
spl set id: 46dcdeaa-ec2a-48d6-b315-fcc3dd71c5e0
unii: PML56A160O
GuanfacineGUANFACINECoupler LLC4973deb3-57ec-1ef3-e063-6294a90aa0352026-01-28Adverse reactionsExact identifier
rxcui: 197746
unii: PML56A160O
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
GuanfacineGUANFACINECoupler LLC266c6819-cd71-55d0-e063-6394a90ab1572026-01-08Adverse reactionsExact identifier
rxcui: 197745
unii: PML56A160O
GuanfacineGUANFACINEAdvagen Pharma Ltd87e1ad56-a7b9-431d-a5d2-d52fb64735c72025-12-31Adverse reactionsExact identifier
rxcui: 197746
rxcui: 197745
unii: PML56A160O
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
GuanfacineGUANFACINEPuraCap Laboratories LLC dba Blu Pharmaceuticalsba089e4c-8623-4159-8230-5c7fd02cdb122025-12-11Adverse reactionsExact identifier
rxcui: 197746
rxcui: 197745
unii: PML56A160O
GUANFACINE HYDROCHLORIDEGUANFACINEChartwell RX, LLCfa7ae501-ee34-4e50-9052-7952e36bbd0e2025-12-10Adverse reactionsExact identifier
rxcui: 197746
rxcui: 197745
unii: PML56A160O
GuanfacineGUANFACINESlate Run Pharmaceuticals, LLCed65ca51-b9b0-43b9-9826-03a7be256a2a2025-12-01Warnings, Adverse reactionsExact identifier
unii: PML56A160O
Guanfacine extended-releaseGUANFACINEBryant Ranch Prepack187bd24b-d69b-4cdf-be4a-c89e9b131b812025-11-05Warnings, Adverse reactionsExact identifier
unii: PML56A160O
GuanfacineGUANFACINEAjanta Pharma USA Inc.830c0be8-2137-46ee-94c6-aa048b7de35f2025-11-05Adverse reactionsExact identifier
rxcui: 197746
rxcui: 197745
unii: PML56A160O
Guanfacine extended-releaseGUANFACINEBryant Ranch Prepack178b649f-8c0f-4fea-a168-3ce4ff52129d2025-10-30Warnings, Adverse reactionsExact identifier
unii: PML56A160O
GUANFACINEGUANFACINEA-S Medication Solutions0836a1d5-f1fc-4b94-9667-667278a74c932025-08-28Warnings, Adverse reactionsExact identifier
unii: PML56A160O
GuanfacineGUANFACINEUnichem Pharmaceuticals (USA), Inc.f4e3c976-8811-4388-92b3-d248d705f8b12025-07-22Warnings, Adverse reactionsExact identifier
unii: PML56A160O
GUANFACINEGUANFACINEBryant Ranch Prepack7db29f50-df23-49b1-ad92-05c42fda4ccd2025-06-27Warnings, Adverse reactionsExact identifier
unii: PML56A160O
IntunivGUANFACINETakeda Pharmaceuticals America, Inc.b972af81-3a37-40be-9fe1-3ddf598525282025-06-23Warnings, Adverse reactionsExact identifier
unii: PML56A160O
Guanfacine HydrochlorideGUANFACINEPrecision Dose, Inc.a80dfdc4-b9a7-4f8e-af67-dea30bc063ac2025-05-27Adverse reactionsExact identifier
rxcui: 197745
unii: PML56A160O
GUANFACINEGUANFACINEAlembic Pharmaceuticals Inc.9db7def2-c6f9-4d7d-a403-fc615358913a2025-05-21Warnings, Adverse reactionsExact identifier
unii: PML56A160O
GUANFACINEGUANFACINEAdvagen Pharma Limitede16beec7-9acd-4cd1-be5c-b666ad7d24302025-04-24Warnings, Adverse reactionsExact identifier
unii: PML56A160O

Reported adverse events (FAERS/openFDA)#

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