FDA.reportPublic FDA data

Quetiapine Fumarate

Product NDC
0054-0230
11-digit product format
000540230
Labeler code
0054
Product ID
0054-0230_73eed8f1-3912-40e6-8084-d8498616ee5d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine Fumarate
Dosage form
TABLET
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA090749
Marketing category
ANDA
Marketing start
2012-03-27
Substance
QUETIAPINE FUMARATE
Active strength
400 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Quetiapine Fumarate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUETIAPINE FUMARATE400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S3PL1B6UJ
Rxcui312743, 312744, 312745, 317174, 616483, 616487

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0054-0230-20Quetiapine Fumarate10 in 1 BLISTER PACKTABLET1026
0054-0230-25Quetiapine Fumarate100 in 1 BOTTLETABLET10026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0230-20EA - Each0054-02309cfe3025-d618-4d35-bd88-1878dc912cf612013-11-04
0054-0230-25EA - Each0054-0230f6363c90-5907-4b17-b367-e91af3e0c42b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
QUETIAPINE FUMARATEACTIVE INGREDIENT2S3PL1B6UJQUETIAPINE FUMARATE TABLET [ROXANE LABORATORIES, INC.]6
QUETIAPINEACTIVE MOIETYBGL0JSY5SIQUETIAPINE FUMARATE TABLET [ROXANE LABORATORIES, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UQUETIAPINE FUMARATE TABLET [ROXANE LABORATORIES, INC.]6
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GQUETIAPINE FUMARATE TABLET [ROXANE LABORATORIES, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30QUETIAPINE FUMARATE TABLET [ROXANE LABORATORIES, INC.]6
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQQUETIAPINE FUMARATE TABLET [ROXANE LABORATORIES, INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4QUETIAPINE FUMARATE TABLET [ROXANE LABORATORIES, INC.]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2QUETIAPINE FUMARATE TABLET [ROXANE LABORATORIES, INC.]6
WATERINACTIVE INGREDIENT059QF0KO0RQUETIAPINE FUMARATE TABLET [ROXANE LABORATORIES, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-0230QUETIAPINE FUMARATE TABLET [HIKMA PHARMACEUTICALS USA INC.]26Current NDC, Legacy NDC, 2 package rows20250328_271e9fb7-3c70-43fc-8279-5adf189f3c22.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312743QUEtiapine fumarate 100 MG Oral TabletPSN271e9fb7-3c70-43fc-8279-5adf189f3c2226
317174QUEtiapine fumarate 200 MG Oral TabletPSN271e9fb7-3c70-43fc-8279-5adf189f3c2226
312744QUEtiapine fumarate 25 MG Oral TabletPSN271e9fb7-3c70-43fc-8279-5adf189f3c2226
312745QUEtiapine fumarate 300 MG Oral TabletPSN271e9fb7-3c70-43fc-8279-5adf189f3c2226
616483QUEtiapine fumarate 400 MG Oral TabletPSN271e9fb7-3c70-43fc-8279-5adf189f3c2226
616487QUEtiapine fumarate 50 MG Oral TabletPSN271e9fb7-3c70-43fc-8279-5adf189f3c2226
312743quetiapine 100 MG Oral TabletSCD271e9fb7-3c70-43fc-8279-5adf189f3c2226
317174quetiapine 200 MG Oral TabletSCD271e9fb7-3c70-43fc-8279-5adf189f3c2226
312744quetiapine 25 MG Oral TabletSCD271e9fb7-3c70-43fc-8279-5adf189f3c2226
312745quetiapine 300 MG Oral TabletSCD271e9fb7-3c70-43fc-8279-5adf189f3c2226
616483quetiapine 400 MG Oral TabletSCD271e9fb7-3c70-43fc-8279-5adf189f3c2226
616487quetiapine 50 MG Oral TabletSCD271e9fb7-3c70-43fc-8279-5adf189f3c2226
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY271e9fb7-3c70-43fc-8279-5adf189f3c2226
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY271e9fb7-3c70-43fc-8279-5adf189f3c2226
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSY271e9fb7-3c70-43fc-8279-5adf189f3c2226
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSY271e9fb7-3c70-43fc-8279-5adf189f3c2226
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSY271e9fb7-3c70-43fc-8279-5adf189f3c2226
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSY271e9fb7-3c70-43fc-8279-5adf189f3c2226
312743QUEtiapine fumarate 100 MG Oral TabletPSN6fc9c8e2-6f34-aa43-e053-2a91aa0ac37711
317174QUEtiapine fumarate 200 MG Oral TabletPSN6fc9c8e2-6f34-aa43-e053-2a91aa0ac37711
312744QUEtiapine fumarate 25 MG Oral TabletPSN6fc9c8e2-6f34-aa43-e053-2a91aa0ac37711
312745QUEtiapine fumarate 300 MG Oral TabletPSN6fc9c8e2-6f34-aa43-e053-2a91aa0ac37711
616483QUEtiapine fumarate 400 MG Oral TabletPSN6fc9c8e2-6f34-aa43-e053-2a91aa0ac37711
616487QUEtiapine fumarate 50 MG Oral TabletPSN6fc9c8e2-6f34-aa43-e053-2a91aa0ac37711
312743quetiapine 100 MG Oral TabletSCD6fc9c8e2-6f34-aa43-e053-2a91aa0ac37711
317174quetiapine 200 MG Oral TabletSCD6fc9c8e2-6f34-aa43-e053-2a91aa0ac37711
312744quetiapine 25 MG Oral TabletSCD6fc9c8e2-6f34-aa43-e053-2a91aa0ac37711
312745quetiapine 300 MG Oral TabletSCD6fc9c8e2-6f34-aa43-e053-2a91aa0ac37711
616483quetiapine 400 MG Oral TabletSCD6fc9c8e2-6f34-aa43-e053-2a91aa0ac37711
616487quetiapine 50 MG Oral TabletSCD6fc9c8e2-6f34-aa43-e053-2a91aa0ac37711
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY6fc9c8e2-6f34-aa43-e053-2a91aa0ac37711
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY6fc9c8e2-6f34-aa43-e053-2a91aa0ac37711
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSY6fc9c8e2-6f34-aa43-e053-2a91aa0ac37711
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSY6fc9c8e2-6f34-aa43-e053-2a91aa0ac37711
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSY6fc9c8e2-6f34-aa43-e053-2a91aa0ac37711
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSY6fc9c8e2-6f34-aa43-e053-2a91aa0ac37711
616483QUEtiapine fumarate 400 MG Oral TabletPSN54c271ab-bfa1-4a53-84cd-648c8a769c1b1
616483quetiapine 400 MG Oral TabletSCD54c271ab-bfa1-4a53-84cd-648c8a769c1b1
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSY54c271ab-bfa1-4a53-84cd-648c8a769c1b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-0230-200005402302010 in 1 BLISTER PACKHistorical
0054-0230-2500054023025100 TABLET in 1 BOTTLE (0054-0230-25) 100 tablet2012-03-270000-00-00NoNoCurrent