Quetiapine

Product NDC
16729-147
11-digit product format
167290147
Labeler code
16729
Product ID
16729-147_438f950d-730b-8926-e063-6294a90a8f66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Accord Healthcare Inc.
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
16729-147-01Quetiapine100 in 1 BOTTLETABLET, FILM COATED10017
16729-147-10Quetiapine30 in 1 BOTTLETABLET, FILM COATED3017
16729-147-17Quetiapine1000 in 1 BOTTLETABLET, FILM COATED100017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-147-01EA - Each16729-147e82537dd-1244-4d89-945f-90fd9f40d8fa12012-07-24
16729-147-10EA - Each16729-147df679c0f-106a-4d70-986d-edc23ff9c1d012013-02-13
16729-147-17EA - Each16729-147300a6657-60ec-4357-89ec-a3d550cb059712012-07-24

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
QUETIAPINE FUMARATEACTIVE INGREDIENT2S3PL1B6UJQUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]5
QUETIAPINEACTIVE MOIETYBGL0JSY5SIQUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UQUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]5
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPQUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTQUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]5
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]5
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XQUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AQUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]5
POVIDONEINACTIVE INGREDIENTFZ989GH94EQUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPQUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]5
QUETIAPINE FUMARATEACTIVE INGREDIENT2S3PL1B6UJQUETIAPINE FUMARATE TABLET, FILM COATED [UNIT DOSE SERVICES]3
QUETIAPINEACTIVE MOIETYBGL0JSY5SIQUETIAPINE FUMARATE TABLET, FILM COATED [UNIT DOSE SERVICES]3
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPQUETIAPINE FUMARATE TABLET, FILM COATED [UNIT DOSE SERVICES]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UQUETIAPINE FUMARATE TABLET, FILM COATED [UNIT DOSE SERVICES]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTQUETIAPINE FUMARATE TABLET, FILM COATED [UNIT DOSE SERVICES]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOQUETIAPINE FUMARATE TABLET, FILM COATED [UNIT DOSE SERVICES]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XQUETIAPINE FUMARATE TABLET, FILM COATED [UNIT DOSE SERVICES]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30QUETIAPINE FUMARATE TABLET, FILM COATED [UNIT DOSE SERVICES]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AQUETIAPINE FUMARATE TABLET, FILM COATED [UNIT DOSE SERVICES]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EQUETIAPINE FUMARATE TABLET, FILM COATED [UNIT DOSE SERVICES]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2QUETIAPINE FUMARATE TABLET, FILM COATED [UNIT DOSE SERVICES]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPQUETIAPINE FUMARATE TABLET, FILM COATED [UNIT DOSE SERVICES]3
QUETIAPINE FUMARATEACTIVE INGREDIENT2S3PL1B6UJQUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]2
QUETIAPINE FUMARATEACTIVE INGREDIENT2S3PL1B6UJQUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
QUETIAPINEACTIVE MOIETYBGL0JSY5SIQUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]2
QUETIAPINEACTIVE MOIETYBGL0JSY5SIQUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPQUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPQUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UQUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UQUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTQUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTQUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]2
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XQUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XQUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AQUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AQUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EQUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EQUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPQUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPQUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-147QUETIAPINE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]16Current NDC, Legacy NDC, 3 package rows20240719_2d77412a-e084-4406-ac33-d882aece9354.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
312743QUEtiapine fumarate 100 MG Oral TabletPSN2d77412a-e084-4406-ac33-d882aece935417
317174QUEtiapine fumarate 200 MG Oral TabletPSN2d77412a-e084-4406-ac33-d882aece935417
312744QUEtiapine fumarate 25 MG Oral TabletPSN2d77412a-e084-4406-ac33-d882aece935417
312745QUEtiapine fumarate 300 MG Oral TabletPSN2d77412a-e084-4406-ac33-d882aece935417
616483QUEtiapine fumarate 400 MG Oral TabletPSN2d77412a-e084-4406-ac33-d882aece935417
616487QUEtiapine fumarate 50 MG Oral TabletPSN2d77412a-e084-4406-ac33-d882aece935417
312743quetiapine 100 MG Oral TabletSCD2d77412a-e084-4406-ac33-d882aece935417
317174quetiapine 200 MG Oral TabletSCD2d77412a-e084-4406-ac33-d882aece935417
312744quetiapine 25 MG Oral TabletSCD2d77412a-e084-4406-ac33-d882aece935417
312745quetiapine 300 MG Oral TabletSCD2d77412a-e084-4406-ac33-d882aece935417
616483quetiapine 400 MG Oral TabletSCD2d77412a-e084-4406-ac33-d882aece935417
616487quetiapine 50 MG Oral TabletSCD2d77412a-e084-4406-ac33-d882aece935417
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY2d77412a-e084-4406-ac33-d882aece935417
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY2d77412a-e084-4406-ac33-d882aece935417
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSY2d77412a-e084-4406-ac33-d882aece935417
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSY2d77412a-e084-4406-ac33-d882aece935417
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSY2d77412a-e084-4406-ac33-d882aece935417
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSY2d77412a-e084-4406-ac33-d882aece935417
312743QUEtiapine fumarate 100 MG Oral TabletPSN8048ac0a-5d4d-4d00-ab9c-7fcac27f0a607
616487QUEtiapine fumarate 50 MG Oral TabletPSN8048ac0a-5d4d-4d00-ab9c-7fcac27f0a607
312743quetiapine 100 MG Oral TabletSCD8048ac0a-5d4d-4d00-ab9c-7fcac27f0a607
616487quetiapine 50 MG Oral TabletSCD8048ac0a-5d4d-4d00-ab9c-7fcac27f0a607
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY8048ac0a-5d4d-4d00-ab9c-7fcac27f0a607
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSY8048ac0a-5d4d-4d00-ab9c-7fcac27f0a607
312743QUEtiapine fumarate 100 MG Oral TabletPSN5dd65e85-430b-4e25-bfe0-5b4c332c39c06
312743QUEtiapine fumarate 100 MG Oral TabletPSNc20c80f1-9e68-4db1-9158-e9be9b7dc4bf6
312744QUEtiapine fumarate 25 MG Oral TabletPSN5dd65e85-430b-4e25-bfe0-5b4c332c39c06
312743quetiapine 100 MG Oral TabletSCDc20c80f1-9e68-4db1-9158-e9be9b7dc4bf6
312743quetiapine 100 MG Oral TabletSCD5dd65e85-430b-4e25-bfe0-5b4c332c39c06
312744quetiapine 25 MG Oral TabletSCD5dd65e85-430b-4e25-bfe0-5b4c332c39c06
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSYc20c80f1-9e68-4db1-9158-e9be9b7dc4bf6
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY5dd65e85-430b-4e25-bfe0-5b4c332c39c06
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSY5dd65e85-430b-4e25-bfe0-5b4c332c39c06
312743QUEtiapine fumarate 100 MG Oral TabletPSN18d1ee40-b529-43d6-b0dc-30ee47d9c33a2
312743quetiapine 100 MG Oral TabletSCD18d1ee40-b529-43d6-b0dc-30ee47d9c33a2
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY18d1ee40-b529-43d6-b0dc-30ee47d9c33a2
312743QUEtiapine fumarate 100 MG Oral TabletPSN5a1a6ce6-741d-6941-e053-2a91aa0a83e71
317174QUEtiapine fumarate 200 MG Oral TabletPSN5a1a6ce6-741d-6941-e053-2a91aa0a83e71
312745QUEtiapine fumarate 300 MG Oral TabletPSN5a1a6ce6-741d-6941-e053-2a91aa0a83e71
312743quetiapine 100 MG Oral TabletSCD5a1a6ce6-741d-6941-e053-2a91aa0a83e71
317174quetiapine 200 MG Oral TabletSCD5a1a6ce6-741d-6941-e053-2a91aa0a83e71
312745quetiapine 300 MG Oral TabletSCD5a1a6ce6-741d-6941-e053-2a91aa0a83e71
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY5a1a6ce6-741d-6941-e053-2a91aa0a83e71
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY5a1a6ce6-741d-6941-e053-2a91aa0a83e71
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSY5a1a6ce6-741d-6941-e053-2a91aa0a83e71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-147-0116729014701100 TABLET, FILM COATED in 1 BOTTLE (16729-147-01) 2012-03-280000-00-00NoNoCurrent
16729-147-101672901471030 in 1 BOTTLEHistorical
16729-147-17167290147171000 TABLET, FILM COATED in 1 BOTTLE (16729-147-17) 2012-03-280000-00-00NoNoCurrent