FDA.reportPublic FDA data

Quetiapine fumarate

Product NDC
60687-382
11-digit product format
606870382
Labeler code
60687
Product ID
60687-382_19c30b16-d7bb-ccf7-e063-6394a90a800b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA201109
Marketing category
ANDA
Marketing start
2017-10-03
Substance
QUETIAPINE FUMARATE
Active strength
400 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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUETIAPINE FUMARATE400 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
60687-382-01Quetiapine fumarate100 in 1 BOX, UNIT-DOSETABLET1007
60687-382-11Quetiapine fumarate1 in 1 BLISTER PACKTABLET17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-382-01EA - Each60687-382091141c0-85d3-43ee-b1a7-52127b34de3e12017-11-06
60687-382-11EA - Each60687-382cb38725f-ee0c-4ec3-bd90-b859d048305f12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-382QUETIAPINE FUMARATE (QUETIAPINE) TABLET [AMERICAN HEALTH PACKAGING]7Current NDC, Legacy NDC, 2 package rows20240615_9f927ae2-a0ae-4953-99ba-8de59ee5bfca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
60687-382-0160687038201100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-382-01) / 1 TABLET in 1 BLISTER PACK (60687-382-11) 100 blister pack2017-10-030000-00-00NoNoCurrent
60687-382-11606870382111 in 1 BLISTER PACKHistorical