FDA.reportPublic FDA data

Quetiapine fumarate

Product NDC
68180-447
11-digit product format
681800447
Labeler code
68180
Product ID
68180-447_a644051f-21f4-4c76-9ed2-e96417d77df9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
quetiapine fumarate
Dosage form
TABLET
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA201109
Marketing category
ANDA
Marketing start
2012-03-27
Substance
QUETIAPINE FUMARATE
Active strength
100 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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUETIAPINE FUMARATE100 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
68180-447-01Quetiapine fumarate100 in 1 BOTTLETABLET10028
68180-447-03Quetiapine fumarate1000 in 1 BOTTLETABLET100028
68180-447-11Quetiapine fumarate10 in 1 BLISTER PACKTABLET1028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-447-01EA - Each68180-447e8eb5484-c5af-4242-97c9-6c483373b5aa12012-07-24
68180-447-03EA - Each68180-44750941324-f829-486a-8d5c-224568a157d712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
QUETIAPINE FUMARATEACTIVE INGREDIENT2S3PL1B6UJQUETIAPINE FUMARATE TABLET [LUPIN PHARMACEUTICALS, INC.]8
QUETIAPINEACTIVE MOIETYBGL0JSY5SIQUETIAPINE FUMARATE TABLET [LUPIN PHARMACEUTICALS, INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UQUETIAPINE FUMARATE TABLET [LUPIN PHARMACEUTICALS, INC.]8
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPQUETIAPINE FUMARATE TABLET [LUPIN PHARMACEUTICALS, INC.]8
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675QUETIAPINE FUMARATE TABLET [LUPIN PHARMACEUTICALS, INC.]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTQUETIAPINE FUMARATE TABLET [LUPIN PHARMACEUTICALS, INC.]8
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357QUETIAPINE FUMARATE TABLET [LUPIN PHARMACEUTICALS, INC.]8
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6QUETIAPINE FUMARATE TABLET [LUPIN PHARMACEUTICALS, INC.]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XQUETIAPINE FUMARATE TABLET [LUPIN PHARMACEUTICALS, INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30QUETIAPINE FUMARATE TABLET [LUPIN PHARMACEUTICALS, INC.]8
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQQUETIAPINE FUMARATE TABLET [LUPIN PHARMACEUTICALS, INC.]8
POVIDONE K30INACTIVE INGREDIENTU725QWY32XQUETIAPINE FUMARATE TABLET [LUPIN PHARMACEUTICALS, INC.]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2QUETIAPINE FUMARATE TABLET [LUPIN PHARMACEUTICALS, INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPQUETIAPINE FUMARATE TABLET [LUPIN PHARMACEUTICALS, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-447QUETIAPINE FUMARATE TABLET [LUPIN PHARMACEUTICALS, INC.]26Current NDC, Legacy NDC, 3 package rows20250309_a951cd63-d329-47c9-965a-582fa73a07c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312743QUEtiapine fumarate 100 MG Oral TabletPSNa951cd63-d329-47c9-965a-582fa73a07c628
317174QUEtiapine fumarate 200 MG Oral TabletPSNa951cd63-d329-47c9-965a-582fa73a07c628
312744QUEtiapine fumarate 25 MG Oral TabletPSNa951cd63-d329-47c9-965a-582fa73a07c628
312745QUEtiapine fumarate 300 MG Oral TabletPSNa951cd63-d329-47c9-965a-582fa73a07c628
616483QUEtiapine fumarate 400 MG Oral TabletPSNa951cd63-d329-47c9-965a-582fa73a07c628
616487QUEtiapine fumarate 50 MG Oral TabletPSNa951cd63-d329-47c9-965a-582fa73a07c628
312743quetiapine 100 MG Oral TabletSCDa951cd63-d329-47c9-965a-582fa73a07c628
317174quetiapine 200 MG Oral TabletSCDa951cd63-d329-47c9-965a-582fa73a07c628
312744quetiapine 25 MG Oral TabletSCDa951cd63-d329-47c9-965a-582fa73a07c628
312745quetiapine 300 MG Oral TabletSCDa951cd63-d329-47c9-965a-582fa73a07c628
616483quetiapine 400 MG Oral TabletSCDa951cd63-d329-47c9-965a-582fa73a07c628
616487quetiapine 50 MG Oral TabletSCDa951cd63-d329-47c9-965a-582fa73a07c628
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSYa951cd63-d329-47c9-965a-582fa73a07c628
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSYa951cd63-d329-47c9-965a-582fa73a07c628
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSYa951cd63-d329-47c9-965a-582fa73a07c628
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSYa951cd63-d329-47c9-965a-582fa73a07c628
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSYa951cd63-d329-47c9-965a-582fa73a07c628
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSYa951cd63-d329-47c9-965a-582fa73a07c628
312743QUEtiapine fumarate 100 MG Oral TabletPSNea9b9ed1-4be0-4dc0-b1dd-239caff5253e13
312743quetiapine 100 MG Oral TabletSCDea9b9ed1-4be0-4dc0-b1dd-239caff5253e13
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSYea9b9ed1-4be0-4dc0-b1dd-239caff5253e13
312743QUEtiapine fumarate 100 MG Oral TabletPSNaeff3ab1-24ff-417a-8bbc-2ffa413dcb873
312743quetiapine 100 MG Oral TabletSCDaeff3ab1-24ff-417a-8bbc-2ffa413dcb873
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSYaeff3ab1-24ff-417a-8bbc-2ffa413dcb873
312743QUEtiapine fumarate 100 MG Oral TabletPSN711f42c5-0719-46de-81fb-3d03801b9ed92
312743QUEtiapine fumarate 100 MG Oral TabletPSN385f7c3d-3299-4b04-947e-de2ee78c82412
317174QUEtiapine fumarate 200 MG Oral TabletPSN711f42c5-0719-46de-81fb-3d03801b9ed92
312743quetiapine 100 MG Oral TabletSCD385f7c3d-3299-4b04-947e-de2ee78c82412
312743quetiapine 100 MG Oral TabletSCD711f42c5-0719-46de-81fb-3d03801b9ed92
317174quetiapine 200 MG Oral TabletSCD711f42c5-0719-46de-81fb-3d03801b9ed92
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY711f42c5-0719-46de-81fb-3d03801b9ed92
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY385f7c3d-3299-4b04-947e-de2ee78c82412
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY711f42c5-0719-46de-81fb-3d03801b9ed92
312743QUEtiapine fumarate 100 MG Oral TabletPSN5074c897-bcf9-7497-e063-6394a90aa7331
312743QUEtiapine fumarate 100 MG Oral TabletPSN5abdd41c-cfe1-d17e-e053-2a91aa0ab9ed1
312743QUEtiapine fumarate 100 MG Oral TabletPSN3624100f-6e3f-a2ad-e063-6294a90a0fc01
312743QUEtiapine fumarate 100 MG Oral TabletPSN1cfc847b-0d8d-fc94-e063-6394a90a311f1
312743quetiapine 100 MG Oral TabletSCD3624100f-6e3f-a2ad-e063-6294a90a0fc01
312743quetiapine 100 MG Oral TabletSCD1cfc847b-0d8d-fc94-e063-6394a90a311f1
312743quetiapine 100 MG Oral TabletSCD5abdd41c-cfe1-d17e-e053-2a91aa0ab9ed1
312743quetiapine 100 MG Oral TabletSCD5074c897-bcf9-7497-e063-6394a90aa7331
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY3624100f-6e3f-a2ad-e063-6294a90a0fc01
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY5abdd41c-cfe1-d17e-e053-2a91aa0ab9ed1
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY1cfc847b-0d8d-fc94-e063-6394a90a311f1
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY5074c897-bcf9-7497-e063-6394a90aa7331

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-447-0168180044701100 TABLET in 1 BOTTLE (68180-447-01) 100 tablet2012-03-270000-00-00NoNoCurrent
68180-447-03681800447031000 TABLET in 1 BOTTLE (68180-447-03) 1000 tablet2012-03-270000-00-00NoNoCurrent
68180-447-116818004471110 TABLET in 1 BLISTER PACK (68180-447-11) 10 tablet2012-03-270000-00-00NoNoCurrent