FDA.reportPublic FDA data

NDC 50090-5884-01 - 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
50090-5884
Requested NDC
50090-5884-01
Package NDCs from labels
50090-5884-0, 50090-5884-1, 50090-5884-01
Manufacturer
A-S Medication Solutions
Effective date
2023-11-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Quetiapine Fumarate - A-S Medication SolutionsA-S Medication Solutions2023-11-24Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5884-0Quetiapine Fumarate30 in 1 BOTTLETABLET3013
50090-5884-1Quetiapine Fumarate90 in 1 BOTTLETABLET9013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5884QUETIAPINE FUMARATE TABLET [A-S MEDICATION SOLUTIONS]13Current NDC, Legacy NDC, 2 package rows20231125_ccacb909-8ee5-4223-bfee-9cfeae470ecf.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5884-0EA - Each50090-588409e2ec2a-5f65-4d01-b6bf-3840221176c312022-06-06
50090-5884-1EA - Each50090-58846e76be3a-c1d8-4cfd-b262-ada4326b851f12022-06-06

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 108 · 2,159 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Quetiapine fumarateQUETIAPINE FUMARATEREMEDYREPACK INC.c6c454c4-3eae-48ae-bf17-5dccdb6591412026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 616487
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINE FUMARATEREMEDYREPACK INC.d38f0f4e-dc0f-4c92-a212-c4da3db748012026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 616483
unii: 2S3PL1B6UJ
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP
Quetiapine FumarateQUETIAPINE FUMARATEREMEDYREPACK INC.3085f68d-e83c-4f59-b058-8bdae7f4e5372026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312743
unii: 2S3PL1B6UJ
Quetiapine FumarateQUETIAPINE FUMARATEREMEDYREPACK INC.b8864cb9-1c6a-4e36-9893-eb1403ee87452026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312744
unii: 2S3PL1B6UJ
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
unii: 15FIX9V2JP
QUETIAPINEQUETIAPINEREMEDYREPACK INC.90da6c48-3282-41dc-b4fa-75d33efa9fee2026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINE FUMARATEREMEDYREPACK INC.ea9b9ed1-4be0-4dc0-b1dd-239caff5253e2026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312743
unii: 2S3PL1B6UJ
QuetiapineQUETIAPINEMajor Pharmaceuticalsb02324b1-e7f0-4cbc-8778-5f7c4a5d194a2026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINE FUMARATEREMEDYREPACK INC.02b19885-2987-4c46-8d2a-5e59656f72e82026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 317174
unii: 2S3PL1B6UJ
QUETIAPINEQUETIAPINEREMEDYREPACK INC.67872105-4ec6-4d46-b3b4-c672c93576d22026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINE FUMARATEREMEDYREPACK INC.695415b1-083d-4540-9f41-bde4b201f8342026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312745
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINE FUMARATEBryant Ranch Prepackc52a9bff-8a03-44f5-9128-799c7dca04672026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 317174
unii: 2S3PL1B6UJ

Reported adverse events (FAERS/openFDA)#

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