FDA.reportPublic FDA data

NDC 63629-4841-05 - 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
63629-4841
Requested NDC
63629-4841-05
Package NDCs from labels
63629-4841-1, 63629-4841-2, 63629-4841-3, 63629-4841-4, 63629-4841-5, 63629-4841-05
Manufacturer
Bryant Ranch Prepack
Effective date
2026-04-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
QUETIAPINE FUMARATE - Bryant Ranch PrepackBryant Ranch Prepack2026-04-02HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63629-4841-12022-01-06These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997
63629-4841-22022-01-06These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997
63629-4841-32022-01-06These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997
63629-4841-12020-01-31These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997
63629-4841-22020-01-31These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997
63629-4841-32020-01-31These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-4841-1QUETIAPINE FUMARATE30 in 1 BOTTLETABLET, FILM COATED301010
63629-4841-2QUETIAPINE FUMARATE60 in 1 BOTTLETABLET, FILM COATED601010
63629-4841-3QUETIAPINE FUMARATE90 in 1 BOTTLETABLET, FILM COATED901010
63629-4841-4QUETIAPINE FUMARATE25 in 1 BOTTLETABLET, FILM COATED251010
63629-4841-5QUETIAPINE FUMARATE120 in 1 BOTTLETABLET, FILM COATED1201010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4841QUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1009Current NDC, Legacy NDC, 5 package rows20240820_a45d8b77-f13d-41c5-8d50-15152fc6f85c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-4841-1EA - Each63629-4841292788f9-441f-439a-a5c3-7080a05b093612015-10-02
63629-4841-2EA - Each63629-4841df4e0f5a-debd-41c9-8dfc-e7bc3603b73412017-03-06
63629-4841-3EA - Each63629-4841f3d5fcc3-5659-44b9-a394-0eeb89b9369512018-06-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
QUETIAPINE FUMARATEACTIVE INGREDIENT2S3PL1B6UJQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
QUETIAPINEACTIVE MOIETYBGL0JSY5SIQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30QUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
POVIDONESINACTIVE INGREDIENTFZ989GH94EQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2QUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001

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 3 of 116 · 2,316 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Quetiapine fumarateQUETIAPINE FUMARATEBryant Ranch Prepack94a81681-381e-4b3b-89ac-e86dcbe7f8902026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312745
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINE FUMARATEBryant Ranch Prepack3eb39b4e-4c79-43b9-a30e-b4221c0e2bd22026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 616487
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINE FUMARATEBryant Ranch Prepackfd9cce28-0052-4b0b-8a66-a1615e082d952026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 616487
unii: 2S3PL1B6UJ
Quetiapine fumarateQUETIAPINECoupler LLC5643d339-50ea-405d-e063-6394a90a3b702026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312744
unii: 2S3PL1B6UJ
Quetiapine FumarateQUETIAPINE FUMARATENorthStar Rx LLCe6e25ef9-2671-489e-8eca-58bedb4f59ab2026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 317174
rxcui: 312745
rxcui: 616483
rxcui: 312744
rxcui: 616487
rxcui: 312743
unii: 2S3PL1B6UJ
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
unii: 15FIX9V2JP
QuetiapineQUETIAPINECoupler LLC56052e5c-0b0b-c296-e063-6394a90a5ad62026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312743
unii: 2S3PL1B6UJ

Reported adverse events (FAERS/openFDA)#

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