FDA.reportPublic FDA data

Clozapine

Product NDC
0378-0972
11-digit product format
003780972
Labeler code
0378
Product ID
0378-0972_a8cef9ad-4bf9-4289-9473-400c8f1a95ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clozapine
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA075417
Marketing category
ANDA
Marketing start
2010-04-20
Substance
CLOZAPINE
Active strength
50 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
CLOZAPINE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ60AR2IKIC
Rxcui197535, 197536, 309374, 429212

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
0378-0972-01Clozapine100 in 1 BOTTLE, PLASTICTABLET10035
0378-0972-02Clozapine100 in 1 BOTTLE, PLASTICTABLET10035

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0972-01EA - Each0378-09720ffc8be0-a681-4a33-ac86-6eb7acba40fb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOZAPINEACTIVE INGREDIENTJ60AR2IKICCLOZAPINE TABLET [MYLAN PHARMACEUTICALS INC.]13
CLOZAPINEACTIVE MOIETYJ60AR2IKICCLOZAPINE TABLET [MYLAN PHARMACEUTICALS INC.]13
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLOZAPINE TABLET [MYLAN PHARMACEUTICALS INC.]13
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCLOZAPINE TABLET [MYLAN PHARMACEUTICALS INC.]13
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCLOZAPINE TABLET [MYLAN PHARMACEUTICALS INC.]13
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACLOZAPINE TABLET [MYLAN PHARMACEUTICALS INC.]13
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLOZAPINE TABLET [MYLAN PHARMACEUTICALS INC.]13
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLOZAPINE TABLET [MYLAN PHARMACEUTICALS INC.]13
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLOZAPINE TABLET [MYLAN PHARMACEUTICALS INC.]13
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCLOZAPINE TABLET [MYLAN PHARMACEUTICALS INC.]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-0972CLOZAPINE TABLET [MYLAN PHARMACEUTICALS INC.]32Current NDC, Legacy NDC, 2 package rows20250417_883b5d43-0339-7dc1-f775-93791fb9b978.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197535cloZAPine 100 MG Oral TabletPSN883b5d43-0339-7dc1-f775-93791fb9b97835
309374cloZAPine 200 MG Oral TabletPSN883b5d43-0339-7dc1-f775-93791fb9b97835
197536cloZAPine 25 MG Oral TabletPSN883b5d43-0339-7dc1-f775-93791fb9b97835
429212cloZAPine 50 MG Oral TabletPSN883b5d43-0339-7dc1-f775-93791fb9b97835
197535clozapine 100 MG Oral TabletSCD883b5d43-0339-7dc1-f775-93791fb9b97835
309374clozapine 200 MG Oral TabletSCD883b5d43-0339-7dc1-f775-93791fb9b97835
197536clozapine 25 MG Oral TabletSCD883b5d43-0339-7dc1-f775-93791fb9b97835
429212clozapine 50 MG Oral TabletSCD883b5d43-0339-7dc1-f775-93791fb9b97835

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-0972-0100378097201100 TABLET in 1 BOTTLE, PLASTIC (0378-0972-01) 100 tablet2010-04-200000-00-00NoNoCurrent
0378-0972-0200378097202100 TABLET in 1 BOTTLE, PLASTIC (0378-0972-02) 100 tablet2020-10-010000-00-00NoNoCurrent