FDA.reportPublic FDA data

Quetiapine fumarate

Product NDC
68001-185
11-digit product format
680010185
Labeler code
68001
Product ID
68001-185_4e775bd2-4ec9-32b4-e063-6294a90acf3d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
quetiapine
Dosage form
TABLET
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA201109
Marketing category
ANDA
Marketing start
2013-02-28
Substance
QUETIAPINE FUMARATE
Active strength
25 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 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
68001-185-00Quetiapine fumarate100 in 1 BOTTLETABLET10021
68001-185-08Quetiapine fumarate1000 in 1 BOTTLETABLET100021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-185-00EA - Each68001-185e867f5c6-fcfb-4511-a82b-b93a9b2efa4a12014-06-03
68001-185-08EA - Each68001-185e231edd2-5577-4e27-bb92-e9577f4215e212014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
QUETIAPINE FUMARATEACTIVE INGREDIENT2S3PL1B6UJQUETIAPINE FUMARATE TABLET [BLUEPOINT LABORATORIES]4
QUETIAPINEACTIVE MOIETYBGL0JSY5SIQUETIAPINE FUMARATE TABLET [BLUEPOINT LABORATORIES]4
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPQUETIAPINE FUMARATE TABLET [BLUEPOINT LABORATORIES]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UQUETIAPINE FUMARATE TABLET [BLUEPOINT LABORATORIES]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675QUETIAPINE FUMARATE TABLET [BLUEPOINT LABORATORIES]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTQUETIAPINE FUMARATE TABLET [BLUEPOINT LABORATORIES]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357QUETIAPINE FUMARATE TABLET [BLUEPOINT LABORATORIES]4
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6QUETIAPINE FUMARATE TABLET [BLUEPOINT LABORATORIES]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XQUETIAPINE FUMARATE TABLET [BLUEPOINT LABORATORIES]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30QUETIAPINE FUMARATE TABLET [BLUEPOINT LABORATORIES]4
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQQUETIAPINE FUMARATE TABLET [BLUEPOINT LABORATORIES]4
POVIDONE K30INACTIVE INGREDIENTU725QWY32XQUETIAPINE FUMARATE TABLET [BLUEPOINT LABORATORIES]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2QUETIAPINE FUMARATE TABLET [BLUEPOINT LABORATORIES]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPQUETIAPINE FUMARATE TABLET [BLUEPOINT LABORATORIES]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-185QUETIAPINE FUMARATE (QUETIAPINE) TABLET [BLUEPOINT LABORATORIES]19Current NDC, Legacy NDC, 2 package rows20250410_874e50ad-5da0-4ac3-9290-79442c91399e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312743QUEtiapine fumarate 100 MG Oral TabletPSN874e50ad-5da0-4ac3-9290-79442c91399e21
317174QUEtiapine fumarate 200 MG Oral TabletPSN874e50ad-5da0-4ac3-9290-79442c91399e21
312744QUEtiapine fumarate 25 MG Oral TabletPSN874e50ad-5da0-4ac3-9290-79442c91399e21
312745QUEtiapine fumarate 300 MG Oral TabletPSN874e50ad-5da0-4ac3-9290-79442c91399e21
616483QUEtiapine fumarate 400 MG Oral TabletPSN874e50ad-5da0-4ac3-9290-79442c91399e21
616487QUEtiapine fumarate 50 MG Oral TabletPSN874e50ad-5da0-4ac3-9290-79442c91399e21
312743quetiapine 100 MG Oral TabletSCD874e50ad-5da0-4ac3-9290-79442c91399e21
317174quetiapine 200 MG Oral TabletSCD874e50ad-5da0-4ac3-9290-79442c91399e21
312744quetiapine 25 MG Oral TabletSCD874e50ad-5da0-4ac3-9290-79442c91399e21
312745quetiapine 300 MG Oral TabletSCD874e50ad-5da0-4ac3-9290-79442c91399e21
616483quetiapine 400 MG Oral TabletSCD874e50ad-5da0-4ac3-9290-79442c91399e21
616487quetiapine 50 MG Oral TabletSCD874e50ad-5da0-4ac3-9290-79442c91399e21
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY874e50ad-5da0-4ac3-9290-79442c91399e21
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY874e50ad-5da0-4ac3-9290-79442c91399e21
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSY874e50ad-5da0-4ac3-9290-79442c91399e21
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSY874e50ad-5da0-4ac3-9290-79442c91399e21
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSY874e50ad-5da0-4ac3-9290-79442c91399e21
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSY874e50ad-5da0-4ac3-9290-79442c91399e21
312743QUEtiapine fumarate 100 MG Oral TabletPSN9f927ae2-a0ae-4953-99ba-8de59ee5bfca7
317174QUEtiapine fumarate 200 MG Oral TabletPSN9f927ae2-a0ae-4953-99ba-8de59ee5bfca7
312744QUEtiapine fumarate 25 MG Oral TabletPSN9f927ae2-a0ae-4953-99ba-8de59ee5bfca7
312745QUEtiapine fumarate 300 MG Oral TabletPSN9f927ae2-a0ae-4953-99ba-8de59ee5bfca7
616483QUEtiapine fumarate 400 MG Oral TabletPSN9f927ae2-a0ae-4953-99ba-8de59ee5bfca7
616487QUEtiapine fumarate 50 MG Oral TabletPSN9f927ae2-a0ae-4953-99ba-8de59ee5bfca7
312743quetiapine 100 MG Oral TabletSCD9f927ae2-a0ae-4953-99ba-8de59ee5bfca7
317174quetiapine 200 MG Oral TabletSCD9f927ae2-a0ae-4953-99ba-8de59ee5bfca7
312744quetiapine 25 MG Oral TabletSCD9f927ae2-a0ae-4953-99ba-8de59ee5bfca7
312745quetiapine 300 MG Oral TabletSCD9f927ae2-a0ae-4953-99ba-8de59ee5bfca7
616483quetiapine 400 MG Oral TabletSCD9f927ae2-a0ae-4953-99ba-8de59ee5bfca7
616487quetiapine 50 MG Oral TabletSCD9f927ae2-a0ae-4953-99ba-8de59ee5bfca7
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY9f927ae2-a0ae-4953-99ba-8de59ee5bfca7
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY9f927ae2-a0ae-4953-99ba-8de59ee5bfca7
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSY9f927ae2-a0ae-4953-99ba-8de59ee5bfca7
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSY9f927ae2-a0ae-4953-99ba-8de59ee5bfca7
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSY9f927ae2-a0ae-4953-99ba-8de59ee5bfca7
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSY9f927ae2-a0ae-4953-99ba-8de59ee5bfca7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-185-0068001018500100 TABLET in 1 BOTTLE (68001-185-00) 100 tablet2013-02-280000-00-00NoNoCurrent
68001-185-08680010185081000 TABLET in 1 BOTTLE (68001-185-08) 1000 tablet2013-02-280000-00-00NoNoCurrent