Quetiapine

Product NDC
55154-7894
11-digit product format
551547894
Labeler code
55154
Product ID
55154-7894_4168e0ed-ac82-4e1b-9ed9-b0680acd55a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
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, 317174, 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
55154-7894-0Quetiapine1 in 1 BLISTER PACKTABLET, FILM COATED112
55154-7894-0Quetiapine10 in 1 BAGTABLET, FILM COATED1012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-7894QUETIAPINE TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]11Current NDC, Legacy NDC, 2 package rows20250507_32bc1ecb-7285-4013-b266-ca783a62d617.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-7894-05515478940010 BLISTER PACK in 1 BAG (55154-7894-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2013-03-010000-00-00NoNoCurrent