FDA.reportPublic FDA data

NDC 70518-3609-01 - Quetiapine Fumarate

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
70518-3609
Requested NDC
70518-3609-01
Package NDCs from labels
70518-3609-0, 70518-3609-1, 70518-3609-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-04-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Quetiapine Fumarate - REMEDYREPACK INC.REMEDYREPACK INC.2026-04-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3609-0Quetiapine Fumarate30 in 1 BLISTER PACKTABLET, FILM COATED307
70518-3609-1Quetiapine Fumarate30 in 1 BLISTER PACKTABLET, FILM COATED307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3609QUETIAPINE FUMARATE TABLET, FILM COATED [REMEDYREPACK INC.]4Current NDC, Legacy NDC, 2 package rows20241122_da5c118f-404c-4453-aa10-a8656b1d7501.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 7 of 144 · 2,878 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Societe Prime and DefendZINC OXIDE SUNSCREENSociete Clinical Skincare5439bd31-5ee1-9bca-e063-6394a90a748c2026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Societe CoverShield Tinted SPFZINC OXIDESociete Clinical Skincare545efbc4-82d4-f126-e063-6294a90a97102026-06-16WarningsExact identifier
unii: 15FIX9V2JP
H-Scars FormulaCALENDULA OFFICINALLIS, SILICEAHealing Natural Oils LLC8433ff00-d815-45e0-b0ec-1448668dd8f82026-06-16WarningsExact identifier
unii: ETJ7Z6XBU4
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
Shield by HEALTHY SKIN LAB MD SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEHEALTHY SKIN LAB LIMITED6838b754-9915-48ff-af35-5338dbd06ac42026-06-15WarningsExact identifier
unii: 15FIX9V2JP
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro544b66c4-49df-556f-e063-6394a90af3ed2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
Quetiapine fumarateQUETIAPINECoupler LLC544f6e91-e61f-c57a-e063-6294a90af9d12026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312745
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINE FUMARATESt. Mary's Medical Park Pharmacy3624100f-6e3f-a2ad-e063-6294a90a0fc02026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312743
unii: 2S3PL1B6UJ
SFL SUNSCREEN - SOL DEFENSE SPF 30TITANIUM DIOXIDE, ZINC OXIDELifeline Medical, Inc5438c185-31c9-c51e-e063-6394a90ae9ef2026-06-14WarningsExact identifier
unii: 15FIX9V2JP
BM Tooth RemineralizationCALC PHOS, CALC FLUOR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro543bc298-ec32-38e9-e063-6394a90aac152026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Nail Fungus Control Extra StrengthCALENDULA OFFICINALIS FLOWERING TOP, SILICON DIOXIDE, AND HYPERICUM PERFORATUMForces of Natured02b88a6-1999-4dcd-91b5-fad88a664fcb2026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Nerve PainARABICA COFFEE BEAN, SILICON DIOXIDE, AND HYPERICUM PERFORATUMForces of Naturea9c3ba2e-9254-4ccd-9fe9-7a360fdf2bb72026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Scar ControlCALENDULA OFFICINALIS FLOWERING TOP, ALLYLTHIOUREA, AND SILICON DIOXIDEForces of Nature595c3423-6b52-48fc-8a95-00b53c1ecc7b2026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM186 DROPSARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICATotal Operations Management LLC DBA:Bestmade Natural Products Micro54243745-bd67-19c1-e063-6394a90a4b722026-06-13WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM186 DROPSARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICABM Private Limited540d8fbe-3bdb-1b54-e063-6394a90a114d2026-06-12WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM5 DROPSAPIS MELL, BAPTISIA, CONIUM MAC, ECHINACEA, EUPATORIUM PERF, SILICEA, THUJA OCCTotal Operations Management LLC DBA:Bestmade Natural Products Micro540e4ee3-596f-4cea-e063-6294a90a6a602026-06-12WarningsExact identifier
unii: ETJ7Z6XBU4
Sunbetter Daily Mineral Protection Broad Spectrum SPF 75 SunscreenTITANIUM DIOXIDE AND ZINC OXIDESKINBETTER SCIENCE LLC54106748-9810-d3ff-e063-6394a90a5b7a2026-06-12WarningsExact identifier
unii: 15FIX9V2JP
Sunbetter Daily Mineral Protection Broad Spectrum SPF 70 Sheer SunscreenTITANIUM DIOXIDE AND ZINC OXIDESKINBETTER SCIENCE LLC5410e0ed-aed5-3279-e063-6294a90a0c3e2026-06-12WarningsExact identifier
unii: 15FIX9V2JP
Quetiapine Extended ReleaseQUETIAPINEREMEDYREPACK INC.995731f7-aace-4140-b699-d6e8975c7c832026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2S3PL1B6UJ
Visine Red Eye Total Comfort Multi-SymptomTETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, AND ZINC SULFATE, UNSPECIFIED FORMKenvue Brands LLC5747edef-7a87-41d7-9594-6c78508b9ba22026-06-11WarningsExact identifier
unii: B697894SGQ

Reported adverse events (FAERS/openFDA)#

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