FDA.reportPublic FDA data

QUETIAPINE FUMARATE

Product NDC
63629-4964
11-digit product format
636294964
Labeler code
63629
Product ID
63629-4964_a11c9785-4dd7-4064-a8b1-171c1677ed71
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
200 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 FUMARATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S3PL1B6UJ
Rxcui317174

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
63629-4964-12022-02-01C16284748780-19d75b9d0-e7dc-f424-e053-dadaa90a57ceThese 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
63629-4964-22022-02-01C16284748780-19d75b9d0-e7dc-f424-e053-dadaa90a57ceThese 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
63629-4964-32022-02-01C16284748780-19d75b9d0-e7dc-f424-e053-dadaa90a57ceThese 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
63629-4964-42022-02-01C16284748780-19d75b9d0-e7dc-f424-e053-dadaa90a57ceThese 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
63629-4964-52022-02-01C16284748780-19d75b9d0-e7dc-f424-e053-dadaa90a57ceThese 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
63629-4964-12020-01-31C16284748780-19d75b9d0-e7dc-f424-e053-dadaa90a57ceThese 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
63629-4964-22020-01-31C16284748780-19d75b9d0-e7dc-f424-e053-dadaa90a57ceThese 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
63629-4964-32020-01-31C16284748780-19d75b9d0-e7dc-f424-e053-dadaa90a57ceThese 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
63629-4964-42020-01-31C16284748780-19d75b9d0-e7dc-f424-e053-dadaa90a57ceThese 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
63629-4964-52020-01-31C16284748780-19d75b9d0-e7dc-f424-e053-dadaa90a57ceThese 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
63629-4964-1QUETIAPINE FUMARATE30 in 1 BOTTLETABLET, FILM COATED301013
63629-4964-2QUETIAPINE FUMARATE100 in 1 BOTTLETABLET, FILM COATED1001013
63629-4964-3QUETIAPINE FUMARATE120 in 1 BOTTLETABLET, FILM COATED1201013
63629-4964-4QUETIAPINE FUMARATE90 in 1 BOTTLETABLET, FILM COATED901013
63629-4964-5QUETIAPINE FUMARATE60 in 1 BOTTLETABLET, FILM COATED601013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-4964-1EA - Each63629-49646e1900ff-233c-49ec-a21e-c0e7b8ec974a12023-09-05
63629-4964-4EA - Each63629-4964c356afbf-9915-42ac-93a8-92d63f84f84112023-09-05
63629-4964-5EA - Each63629-49641ddd8912-cf95-4cae-8788-d5acedff195712023-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
QUETIAPINE FUMARATEACTIVE INGREDIENT2S3PL1B6UJQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1003
QUETIAPINEACTIVE MOIETYBGL0JSY5SIQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1003
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1003
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1003
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4QUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1003
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1003
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30QUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1003
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1003
POVIDONESINACTIVE INGREDIENTFZ989GH94EQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1003
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2QUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1003
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4964QUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1012Current NDC, Legacy NDC, 5 package rows20240820_4e1e5249-1cb7-4cc2-ad5a-cdeeee2f494f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317174QUEtiapine fumarate 200 MG Oral TabletPSN4e1e5249-1cb7-4cc2-ad5a-cdeeee2f494f1013
317174quetiapine 200 MG Oral TabletSCD4e1e5249-1cb7-4cc2-ad5a-cdeeee2f494f1013
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY4e1e5249-1cb7-4cc2-ad5a-cdeeee2f494f1013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-4964-16362949640130 TABLET, FILM COATED in 1 BOTTLE (63629-4964-1) 2013-03-290000-00-00NoNoCurrent
63629-4964-263629496402100 TABLET, FILM COATED in 1 BOTTLE (63629-4964-2) 2013-04-250000-00-00NoNoCurrent
63629-4964-363629496403120 TABLET, FILM COATED in 1 BOTTLE (63629-4964-3) 2024-08-080000-00-00NoNoCurrent
63629-4964-46362949640490 TABLET, FILM COATED in 1 BOTTLE (63629-4964-4) 2016-12-150000-00-00NoNoCurrent
63629-4964-56362949640560 TABLET, FILM COATED in 1 BOTTLE (63629-4964-5) 2017-09-210000-00-00NoNoCurrent