FDA.reportPublic FDA data

Clozapine

Product NDC
51079-922
11-digit product format
510790922
Labeler code
51079
Product ID
51079-922_4358c8d6-f05a-65d8-e063-6294a90a422a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clozapine
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA075417
Marketing category
ANDA
Marketing start
1999-11-15
Substance
CLOZAPINE
Active strength
100 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
Clozapine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOZAPINE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ60AR2IKIC
Rxcui197535, 197536, 309374

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
51079-922-01Clozapine1 in 1 BLISTER PACKTABLET119
51079-922-20Clozapine100 in 1 CARTONTABLET10019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-922-01EA - Each51079-922ff6ae99c-08e1-4327-a233-7856e29fc04d12012-07-24
51079-922-20EA - Each51079-92278f536f7-2ff9-44b9-8f1f-e8cb4322bf8f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOZAPINEACTIVE INGREDIENTJ60AR2IKICCLOZAPINE TABLET [MYLAN INSTITUTIONAL INC.]4
CLOZAPINEACTIVE MOIETYJ60AR2IKICCLOZAPINE TABLET [MYLAN INSTITUTIONAL INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLOZAPINE TABLET [MYLAN INSTITUTIONAL INC.]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCLOZAPINE TABLET [MYLAN INSTITUTIONAL INC.]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCLOZAPINE TABLET [MYLAN INSTITUTIONAL INC.]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACLOZAPINE TABLET [MYLAN INSTITUTIONAL INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLOZAPINE TABLET [MYLAN INSTITUTIONAL INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLOZAPINE TABLET [MYLAN INSTITUTIONAL INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLOZAPINE TABLET [MYLAN INSTITUTIONAL INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCLOZAPINE TABLET [MYLAN INSTITUTIONAL INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51079-922CLOZAPINE TABLET [MYLAN INSTITUTIONAL INC.]17Current NDC, Legacy NDC, 2 package rows20240925_d5c8a456-6f3c-4963-b321-4ed746f690e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197535cloZAPine 100 MG Oral TabletPSNd5c8a456-6f3c-4963-b321-4ed746f690e419
309374cloZAPine 200 MG Oral TabletPSNd5c8a456-6f3c-4963-b321-4ed746f690e419
197536cloZAPine 25 MG Oral TabletPSNd5c8a456-6f3c-4963-b321-4ed746f690e419
197535clozapine 100 MG Oral TabletSCDd5c8a456-6f3c-4963-b321-4ed746f690e419
309374clozapine 200 MG Oral TabletSCDd5c8a456-6f3c-4963-b321-4ed746f690e419
197536clozapine 25 MG Oral TabletSCDd5c8a456-6f3c-4963-b321-4ed746f690e419

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-922-01510790922011 in 1 BLISTER PACKHistorical
51079-922-2051079092220100 BLISTER PACK in 1 CARTON (51079-922-20) / 1 TABLET in 1 BLISTER PACK (51079-922-01) 100 blister pack1999-11-150000-00-00NoNoCurrent