FDA.reportPublic FDA data

Quetiapine

Product NDC
0904-6640
11-digit product format
009046640
Labeler code
0904
Product ID
0904-6640_50f28d31-26e7-46fb-8bcb-207554f50708
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA201504
Marketing category
ANDA
Marketing start
2013-03-01
Substance
QUETIAPINE FUMARATE
Active strength
100 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
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
0904-6640-61Quetiapine1 in 1 BLISTER PACKTABLET, FILM COATED18
0904-6640-61Quetiapine100 in 1 CARTONTABLET, FILM COATED1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6640-61EA - Each0904-664027e8d2e2-af70-4c22-b69c-546dbc6d1b7a12017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6640QUETIAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]7Current NDC, Legacy NDC, 2 package rows20250410_f9447739-9e21-4232-950f-174c0496ab66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312743QUEtiapine fumarate 100 MG Oral TabletPSN32bc1ecb-7285-4013-b266-ca783a62d61712
317174QUEtiapine fumarate 200 MG Oral TabletPSN32bc1ecb-7285-4013-b266-ca783a62d61712
312744QUEtiapine fumarate 25 MG Oral TabletPSN32bc1ecb-7285-4013-b266-ca783a62d61712
616487QUEtiapine fumarate 50 MG Oral TabletPSN32bc1ecb-7285-4013-b266-ca783a62d61712
312743quetiapine 100 MG Oral TabletSCD32bc1ecb-7285-4013-b266-ca783a62d61712
317174quetiapine 200 MG Oral TabletSCD32bc1ecb-7285-4013-b266-ca783a62d61712
312744quetiapine 25 MG Oral TabletSCD32bc1ecb-7285-4013-b266-ca783a62d61712
616487quetiapine 50 MG Oral TabletSCD32bc1ecb-7285-4013-b266-ca783a62d61712
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY32bc1ecb-7285-4013-b266-ca783a62d61712
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY32bc1ecb-7285-4013-b266-ca783a62d61712
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSY32bc1ecb-7285-4013-b266-ca783a62d61712
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSY32bc1ecb-7285-4013-b266-ca783a62d61712
312743QUEtiapine fumarate 100 MG Oral TabletPSNf9447739-9e21-4232-950f-174c0496ab668
317174QUEtiapine fumarate 200 MG Oral TabletPSNf9447739-9e21-4232-950f-174c0496ab668
312744QUEtiapine fumarate 25 MG Oral TabletPSNf9447739-9e21-4232-950f-174c0496ab668
312745QUEtiapine fumarate 300 MG Oral TabletPSNf9447739-9e21-4232-950f-174c0496ab668
616483QUEtiapine fumarate 400 MG Oral TabletPSNf9447739-9e21-4232-950f-174c0496ab668
616487QUEtiapine fumarate 50 MG Oral TabletPSNf9447739-9e21-4232-950f-174c0496ab668
312743quetiapine 100 MG Oral TabletSCDf9447739-9e21-4232-950f-174c0496ab668
317174quetiapine 200 MG Oral TabletSCDf9447739-9e21-4232-950f-174c0496ab668
312744quetiapine 25 MG Oral TabletSCDf9447739-9e21-4232-950f-174c0496ab668
312745quetiapine 300 MG Oral TabletSCDf9447739-9e21-4232-950f-174c0496ab668
616483quetiapine 400 MG Oral TabletSCDf9447739-9e21-4232-950f-174c0496ab668
616487quetiapine 50 MG Oral TabletSCDf9447739-9e21-4232-950f-174c0496ab668
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSYf9447739-9e21-4232-950f-174c0496ab668
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSYf9447739-9e21-4232-950f-174c0496ab668
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSYf9447739-9e21-4232-950f-174c0496ab668
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSYf9447739-9e21-4232-950f-174c0496ab668
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSYf9447739-9e21-4232-950f-174c0496ab668
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSYf9447739-9e21-4232-950f-174c0496ab668

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6640-6100904664061100 BLISTER PACK in 1 CARTON (0904-6640-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2013-03-010000-00-00NoNoCurrent