CLOZAPINE

Product NDC
55154-3568
11-digit product format
551543568
Labeler code
55154
Product ID
55154-3568_d8831827-913d-4672-922a-629f5d93942e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLOZAPINE
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA206433
Marketing category
ANDA
Marketing start
2016-11-29
Substance
CLOZAPINE
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
CLOZAPINE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOZAPINE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ60AR2IKIC
Rxcui197535

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fde12e54-43fa-cc16-3015-4c000a7b8d3eProduct name520250812
0901063f-b37f-4bf1-8be6-1e2a469e57bcProduct name220180209
e01fb60f-a608-2c68-dfdd-23e6433ece68Product name520180209
7a7f58c4-be43-7e82-4dfc-128bbed4230aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-3568-0CLOZAPINE10 in 1 BAGTABLET106
55154-3568-0CLOZAPINE1 in 1 BLISTER PACKTABLET16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-3568CLOZAPINE TABLET [CARDINAL HEALTH 107, LLC]4Current NDC, Legacy NDC, 2 package rows20250108_7c748f8a-73ce-4bd3-aa30-9c66657f06ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197535cloZAPine 100 MG Oral TabletPSN7c748f8a-73ce-4bd3-aa30-9c66657f06ec6
197535clozapine 100 MG Oral TabletSCD7c748f8a-73ce-4bd3-aa30-9c66657f06ec6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-3568-05515435680010 BLISTER PACK in 1 BAG (55154-3568-0) / 1 TABLET in 1 BLISTER PACK10 blister pack2016-11-290000-00-00NoNoCurrent