FDA.reportPublic FDA data

Quetiapine fumarate

Product NDC
68180-445
11-digit product format
681800445
Labeler code
68180
Product ID
68180-445_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
25 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 FUMARATE25 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
68180-445-01Quetiapine fumarate100 in 1 BOTTLETABLET10028
68180-445-03Quetiapine fumarate1000 in 1 BOTTLETABLET100028
68180-445-11Quetiapine fumarate10 in 1 BLISTER PACKTABLET1028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-445-01EA - Each68180-445538b1778-122b-407f-8775-933934b9379f12012-07-24
68180-445-03EA - Each68180-445657dde1a-8237-4c94-b48e-8ad343033bb912012-07-24

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
68180-445QUETIAPINE 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
312744QUEtiapine fumarate 25 MG Oral TabletPSNf3c91d05-038b-40f4-8c1f-2910773ec5672
312744quetiapine 25 MG Oral TabletSCDf3c91d05-038b-40f4-8c1f-2910773ec5672
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSYf3c91d05-038b-40f4-8c1f-2910773ec5672
312744QUEtiapine fumarate 25 MG Oral TabletPSN227b8b2b-a238-efb4-e063-6394a90acc7e1
312744quetiapine 25 MG Oral TabletSCD227b8b2b-a238-efb4-e063-6394a90acc7e1
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSY227b8b2b-a238-efb4-e063-6394a90acc7e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-445-0168180044501100 TABLET in 1 BOTTLE (68180-445-01) 100 tablet2012-03-270000-00-00NoNoCurrent
68180-445-03681800445031000 TABLET in 1 BOTTLE (68180-445-03) 1000 tablet2012-03-270000-00-00NoNoCurrent
68180-445-116818004451110 TABLET in 1 BLISTER PACK (68180-445-11) 10 tablet2012-03-270000-00-00NoNoCurrent