FDA.reportPublic FDA data

NDC 63629-4776-04 - 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
63629-4776
Requested NDC
63629-4776-04
Package NDCs from labels
63629-4776-1, 63629-4776-2, 63629-4776-3, 63629-4776-4, 63629-4776-5, 63629-4776-6, 63629-4776-04
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
63629-4776-12022-02-11These 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
63629-4776-22022-02-11These 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
63629-4776-12019-11-27These 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
63629-4776-22019-11-27These 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
63629-4776-1QUETIAPINE FUMARATE100 in 1 BOTTLETABLET, FILM COATED1001006
63629-4776-2QUETIAPINE FUMARATE30 in 1 BOTTLETABLET, FILM COATED301006
63629-4776-3QUETIAPINE FUMARATE120 in 1 BOTTLETABLET, FILM COATED1201006
63629-4776-4QUETIAPINE FUMARATE60 in 1 BOTTLETABLET, FILM COATED601006
63629-4776-5QUETIAPINE FUMARATE90 in 1 BOTTLETABLET, FILM COATED901006
63629-4776-6QUETIAPINE FUMARATE15 in 1 BOTTLETABLET, FILM COATED151006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4776QUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1005Current NDC, Legacy NDC, 6 package rows20240820_45c4c3a4-3acc-413e-9746-4816d513fac6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-4776-2EA - Each63629-4776a69004c2-ee69-4494-95df-bfca6e3d965b12020-04-20
63629-4776-4EA - Each63629-4776f188a6d1-1912-4661-a3fd-22c22865be4e12022-03-09
63629-4776-5EA - Each63629-47768725127e-7bd5-408b-870e-f0c771a2703812022-03-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
QUETIAPINE FUMARATEACTIVE INGREDIENT2S3PL1B6UJQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
QUETIAPINEACTIVE MOIETYBGL0JSY5SIQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30QUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POVIDONEINACTIVE INGREDIENTFZ989GH94EQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2QUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000

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 1 of 117 · 2,327 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
Dr.Harry EYES PROTECTIONPOLYETHYLENE GLYCOL 400 1% EYES PROTECTIONWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9fe033-89d3-da62-e063-6294a90a45032026-09-03WarningsExact identifier
unii: B697894SGQ
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
Quetiapine fumarateQUETIAPINE FUMARATEPreferred Pharmaceuticals Inc.711f42c5-0719-46de-81fb-3d03801b9ed92026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 317174
rxcui: 312743
unii: 2S3PL1B6UJ
Quetiapine FumarateQUETIAPINE FUMARATEPreferred Pharmaceuticals Inc.717b55c4-a23f-4d74-8023-0f4e14d89ec82026-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 616487
unii: 2S3PL1B6UJ
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: FZ989GH94E
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: FZ989GH94E
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: FZ989GH94E
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Quetiapine fumarateQUETIAPINE FUMARATENuCare Pharmaceuticals,Inc.227b8b2b-a238-efb4-e063-6394a90acc7e2026-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312744
unii: 2S3PL1B6UJ
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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