FDA.reportPublic FDA data

NDC 50090-3333-01 - 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
50090-3333
Requested NDC
50090-3333-01
Package NDCs from labels
50090-3333-0, 50090-3333-1, 50090-3333-01
Manufacturer
A-S Medication Solutions
Effective date
2024-12-20
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 Solutions2024-12-20Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3333-0Quetiapine Fumarate30 in 1 BOTTLETABLET3020
50090-3333-1Quetiapine Fumarate90 in 1 BOTTLETABLET9020

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3333QUETIAPINE FUMARATE TABLET [A-S MEDICATION SOLUTIONS]20Current NDC, Legacy NDC, 2 package rows20241222_132a2483-7e49-4b0c-9db4-e6e578697fd9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3333-0EA - Each50090-3333a5750586-1b4f-4b75-b8f6-e269c2ecfce012019-05-02
50090-3333-1EA - Each50090-333315755b40-a762-4ec9-bcf9-6358aeca3b3312025-01-14

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 13 of 117 · 2,335 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SEROQUEL XRQUETIAPINEH2-Pharma, LLCab959a35-d0ba-4f18-8f2e-6619d88b16e32026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2S3PL1B6UJ
Quetiapine FumarateQUETIAPINE FUMARATEBryant Ranch Prepackf0ad842c-a0c2-4855-a55b-353b5338980f2026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312745
unii: 2S3PL1B6UJ
Quetiapine FumarateQUETIAPINE FUMARATEREMEDYREPACK INC.41dbd5a5-4ae2-4ac1-8135-0fdac5c170b52026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312743
unii: 2S3PL1B6UJ
uLOOK Sunscreen SPF 50SUNSCREENHAMEX GLOBAL COSMETICS LLC4e05588c-486b-60e0-e063-6294a90af4572026-04-09WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena MINERAL UV TINT FACE DEEP SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef430e8-cdc8-2897-e063-6394a90a3ac72026-04-08WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena MINERAL UV TINT FACE LIGHT SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef4a822-a7ab-b374-e063-6394a90a85082026-04-08WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena MINERAL UV TINT FACE MEDIUM SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef4d44e-3421-535f-e063-6294a90a2fea2026-04-08WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30 and Neutrogena Collagen Bank MoisturizerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAcupac Packaging, Inc.4ef5baf7-00b1-97aa-e063-6294a90aab9c2026-04-08WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena Mineral Ultra Sheer Face SPF 70TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef5dcd4-b2d0-bcd1-e063-6294a90a871f2026-04-08WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena Mineral Invisible Daily Defense Face Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef6b5fb-5495-001c-e063-6394a90ab7b32026-04-08WarningsExact identifier
unii: 15FIX9V2JP
Nu Colour Bioadaptive BB Plus Foundation - Light GoldenTITANIUM DIOXIDENSE Products, Inc.faae6f47-19f3-41cb-8e0d-388569b5c73d2026-04-07WarningsExact identifier
unii: 15FIX9V2JP
Ultra SunscreenOCTINOXATE, OCTISALATE, TITANIUM DIOXIDEJiangsu Senwo Medical Technology Co., Ltd.4ed974b8-6c11-08e0-e063-6294a90a77132026-04-07WarningsExact identifier
unii: 15FIX9V2JP
Quetiapine FumarateQUETIAPINE FUMARATENuCare Pharmaceuticals,Inc.16f48034-b8c9-ab2b-e063-6294a90adf652026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA201504
rxcui: 312745
unii: 2S3PL1B6UJ
Neutrogena MINERAL UV TINT FACE MEDIUM DEEP SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc4ee39bbf-b7d7-8f87-e063-6294a90a25392026-04-07WarningsExact identifier
unii: 15FIX9V2JP
Nu Colour Bioadaptive BB plus Foundation - BeigeTITANIUM DIOXIDENSE Products, Inc.f74e83fe-41a0-4998-ae53-30ed5af475922026-04-07WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE 8%, ZINC OXIDE 8%Farmacias De Similares TX LLC4ecd0add-11c9-cf3b-e063-6394a90adff62026-04-06WarningsExact identifier
unii: 1K09F3G675
EltaMD Skincare UV AOX Elements SPF50 TintedTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc2c74209d-9b88-4c32-ad42-cd6de16c1fef2026-04-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV Restore TintedTITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENCP Skin Health Group, Inc4fc18856-01b3-43ed-9e1b-b4394e31aa3c2026-04-03WarningsExact identifier
unii: 15FIX9V2JP
QuetiapineQUETIAPINEBryant Ranch Prepackcb989abf-7d73-4ab9-a07f-a8c9de50389f2026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 616483
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINEBluePoint Laboratories874e50ad-5da0-4ac3-9290-79442c91399e2026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 317174
rxcui: 312745
rxcui: 616483
rxcui: 312744
rxcui: 616487
rxcui: 312743
unii: 2S3PL1B6UJ

Reported adverse events (FAERS/openFDA)#

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