FDA.reportPublic FDA data

QUETIAPINE FUMARATE

Product NDC
63629-4776
11-digit product format
636294776
Labeler code
63629
Product ID
63629-4776_c6322605-e2f5-4656-96c2-daac4886cdda
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
QUETIAPINE FUMARATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202152
Marketing category
ANDA
Marketing start
2012-03-28
Substance
QUETIAPINE FUMARATE
Active strength
100 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
QUETIAPINE FUMARATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUETIAPINE FUMARATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S3PL1B6UJ
Rxcui312743

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ef42f82-f087-0d2c-105f-f791ca69210eProduct name820250729
21205abd-8c89-4943-9f85-908f3d4fc3bbProduct name520230501

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-4776-12022-02-11C16284748780-19855d018-e939-cd31-e053-dbdaa90ab51aThese 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
63629-4776-22022-02-11C16284748780-19855d018-e939-cd31-e053-dbdaa90ab51aThese 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
63629-4776-12019-11-27C16284748780-19855d018-e939-cd31-e053-dbdaa90ab51aThese 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
63629-4776-22019-11-27C16284748780-19855d018-e939-cd31-e053-dbdaa90ab51aThese 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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312743QUEtiapine fumarate 100 MG Oral TabletPSN45c4c3a4-3acc-413e-9746-4816d513fac61006
312743quetiapine 100 MG Oral TabletSCD45c4c3a4-3acc-413e-9746-4816d513fac61006
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY45c4c3a4-3acc-413e-9746-4816d513fac61006

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-4776-163629477601100 TABLET, FILM COATED in 1 BOTTLE (63629-4776-1) 2012-08-020000-00-00NoNoCurrent
63629-4776-26362947760230 TABLET, FILM COATED in 1 BOTTLE (63629-4776-2) 2013-03-290000-00-00NoNoCurrent
63629-4776-363629477603120 TABLET, FILM COATED in 1 BOTTLE (63629-4776-3) 2013-05-140000-00-00NoNoCurrent
63629-4776-46362947760460 TABLET, FILM COATED in 1 BOTTLE (63629-4776-4) 2016-03-230000-00-00NoNoCurrent
63629-4776-56362947760590 TABLET, FILM COATED in 1 BOTTLE (63629-4776-5) 2018-05-140000-00-00NoNoCurrent
63629-4776-66362947760615 TABLET, FILM COATED in 1 BOTTLE (63629-4776-6) 2024-08-080000-00-00NoNoCurrent