NDC 70518-4266-01 - Guanfacine extended-release

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
70518-4266
Requested NDC
70518-4266-01
Package NDCs from labels
70518-4266-1, 70518-4266-0, 70518-4266-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-09-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Guanfacine extended-release - REMEDYREPACK INC.REMEDYREPACK INC.2026-09-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4266-0Guanfacine extended-release100 in 1 BOXTABLET, EXTENDED RELEASE1004
70518-4266-1Guanfacine extended-release1 in 1 POUCHTABLET, EXTENDED RELEASE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4266GUANFACINE EXTENDED-RELEASE (GUANFACINE) TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]3Current NDC, 2 package rows20250529_8348e63a-5cbc-489e-b7bf-046c65ba2e8e.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 4 of 35 · 698 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro53bb3927-6053-eb3d-e063-6394a90a5ddf2026-06-08WarningsExact identifier
unii: ETJ7Z6XBU4
Guanfacine Extended-ReleaseGUANFACINEREMEDYREPACK INC.3ec4fed6-cafc-49a0-9540-8d70ac4357692026-06-08Warnings, Adverse reactionsExact identifier
rxcui: 862013
ScrofularoforceRUMEX CRISPUS, XANTHOXYLUM FRAXINEUM, LYMPH NODE (SUIS), SCROPHULARIA NODOSA, BARYTA CARBONICA, BARYTA MURIATICA, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, HELLEBORUS NIGER, IODIUM, KALI PHOSPHORICUM, LACHESIS MUTUS, NATRUM PHOSPHORICUM, SILICEA, JUNIPERUS VIRGINIANABioActive Nutritional, Inc.737cd410-0405-41b0-b7f2-29bb200378492026-06-08WarningsExact identifier
unii: ETJ7Z6XBU4
VAXBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, TRIFOLIUM PRATENSE, ARNICA MONTANA, CALENDULA OFFICINALIS, CHELIDONIUM MAJUS, LEPTANDRA VIRGINICA, LIGUSTICUM PORTERI, LOMATIUM DISSECTUM, MYRRHA, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, TRIGONELLA FOENUM-GRAECUM, URTICA DIOICA, HYDRASTIS CANADENSIS, ASTRAGALUS MEMBRANACEUS, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, LYCOPODIUM CLAVATUM, RHUS TOX, SILICEA,BioActive Nutritional, Inc.faa4a678-321a-4982-a5d4-01b713e6862d2026-06-08WarningsExact identifier
unii: ETJ7Z6XBU4
VermexARTEMISIA VULGARIS, CINA, TEUCRIUM MARUM, SPIGELIA ANTHELMIA, FILIX MAS, CALCAREA CARBONICA, GRAPHITES, MERCURIUS CORROSIVUS, SABADILLA, SILICEA, TANACETUM VULGARE, ASCARIS LUMBRICOIDES, TAENIA SOLIUMBioActive Nutritional, Inc.6be5fbcf-bb22-4b20-b65a-d943c516adf92026-06-04WarningsExact identifier
unii: ETJ7Z6XBU4
GuanfacineGUANFACINESun Pharmaceutical Industries, Inc2d0a0f8e-5098-4ee2-a4ee-d026789923e22026-06-04Warnings, Adverse reactionsExact identifier
rxcui: 862013
rxcui: 862025
rxcui: 862006
rxcui: 862019
unii: PML56A160O
BM Silicea Icing SugarSILICEA ICING SUGARTotal Operations Management LLC DBA:Bestmade Natural Products Micro535ba100-627f-36b4-e063-6394a90a33732026-06-03WarningsExact identifier
unii: ETJ7Z6XBU4
BM Tooth RemineralizationCALC PHOS, CALC FLUOR, SILICEABM Private Limited5331dc40-2ac8-5fce-e063-6394a90a58752026-06-01WarningsExact identifier
unii: ETJ7Z6XBU4
Guanfacine HydrochlorideGUANFACINEA-S Medication Solutions9f967d68-5aff-4955-8c79-69febf7c38ad2026-05-22Adverse reactionsExact identifier
unii: PML56A160O
DentaforceANTIMONIUM CRUDUM, BELLADONNA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, SEPIA, SILICEA, HYDROFLUORICUM ACIDUMBioActive Nutritional, Inc.82321547-e04a-42ff-aa39-6a192638e5a22026-05-18WarningsExact identifier
unii: ETJ7Z6XBU4
C07 STRONG LIGAMENTS AND JOINTSARNICA MONTANA, ASCORBICUM ACIDUM, BOS TAURUS LYMPH VESSEL, INTERVERTEBRAL FIBROCARTILAGE, BOS TAURUS MESENCHYME, CALCAREA PHOSPHORICA, CARTILAGO SUIS, FORMICUM ACIDUM, LAPIS ALBUS, PINUS MONTANA LEAFY TWIG, RHAMNUS CALIFORNICA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SUS SCROFA JOINT ENVELOPE, SUS SCROFA LIGAMENT, SUS SCROFA MENISCUS, SUS SCROFA PARATHYROID GLAND, SUS SCROFA VEIN, SYMPHYTUM OFFICINALEApex Energetics Inc.bccf8c83-a6cd-e58c-e053-2a95a90a43d72026-05-13WarningsExact identifier
unii: ETJ7Z6XBU4
Acne ReliefBELLADONNA, SILICEA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, KALI BROMATUM, LEDUM PALUSTRE, NATRUM MURIATICUM, SELENIUM, SULPHURNaturalCare487b1373-b78c-4510-964a-6ab0fe781ff42026-05-08WarningsExact identifier
unii: ETJ7Z6XBU4
DentastatALLIUM SATIVUM, BERBERIS VULGARIS, FUCUS VESICULOSUS, PHYTOLACCA DECANDRA, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, IODIUM, MERCURIUS SOLUBILIS, NICCOLUM METALLICUM, SILICEA, ZINCUM METALLICUM, PLATINUM METALLICUMEnergique, Inc.12786efd-df42-4321-bfdf-88f542d387bb2026-05-06WarningsExact identifier
unii: ETJ7Z6XBU4
Guanfacine extended-releaseGUANFACINEApotex Corp.1c492e87-3406-ddb8-aaf2-e609c2ded5032026-05-06Warnings, Adverse reactionsExact identifier
application number: ANDA205430
ndc (product): 60505-3928
rxcui: 862013
rxcui: 862025
rxcui: 862006
rxcui: 862019
spl id: be71bf36-161d-d944-6044-1bbe8d133d28
spl set id: 1c492e87-3406-ddb8-aaf2-e609c2ded503
unii: PML56A160O
Age Defiance Pro7-OXO-DEHYDROEPIANDROSTERONE-3B-ACETATE, CALCAREA CARBONICA, CONIUM MACULATUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYDROFLUORICUM ACIDUM, HYPOPHYSIS SUIS, LYCOPODIUM CLAVATUM, SELENIUM METALLICUM, SEPIA, SILICEA, HUMAN GROWTH HORMONEEnergique, Inc.d528bdbe-fb75-4b13-9cbc-efa2177d74d82026-05-06WarningsExact identifier
unii: ETJ7Z6XBU4
Pollen HayfeverADRENALINUM, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM IODATUM, MUGWORT POLLEN (ARTEMISIA VULGARIS), BELLIS PERENNIS, BRASSICA SPP, CHENOPODIUM ALBUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, ALFALFA POLLEN (MEDICAGO SATIVA), PHLEUM PRATENSE, YELLOW DOCK POLLEN (RUMEX CRISPUS), SABADILLA, SILICEA, GOLDENROD POLLEN (SOLIDAGO CANADENSIS), DANDELION POLLEN (TARAXACUM OFFICINALE), RED CLOVER POLLEN (TRIFOLIUM PRATENSE), XANTHIUM STRUMARIUMNaturalCare00665933-176e-4f16-b6ee-b55217b8abb32026-05-05WarningsExact identifier
unii: ETJ7Z6XBU4
GuanfacineGUANFACINEMajor Pharmaceuticals400be431-ad6c-4783-a513-ca8b47bf43ee2026-05-04Adverse reactionsExact identifier
unii: PML56A160O
Hydrate ICOFFEA TOSTA, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEABioActive Nutritional, Inc.c0c8d350-0257-4484-acd8-f852350173db2026-04-30WarningsExact identifier
unii: ETJ7Z6XBU4
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

Reported adverse events (FAERS/openFDA)#

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