FDA.reportPublic FDA data

Clozapine

Product NDC
0378-3813
11-digit product format
003783813
Labeler code
0378
Product ID
0378-3813_435c523e-e4fc-4653-9eb7-ff9c194b42ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clozapine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA201824
Marketing category
ANDA
Marketing start
2015-11-02
Substance
CLOZAPINE
Active strength
25 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
CLOZAPINE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ60AR2IKIC
Rxcui476177, 476179, 996921, 1006801

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
0378-3813-01Clozapine100 in 1 BOTTLE, PLASTICTABLET, ORALLY DISINTEGRATING10026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-3813-01EA - Each0378-3813a8e0f893-0d02-43fd-a12e-e418dc2ece0e12015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOZAPINEACTIVE INGREDIENTJ60AR2IKICCLOZAPINE TABLET, ORALLY DISINTEGRATING [MYLAN PHARMACEUTICALS INC.]6
CLOZAPINEACTIVE MOIETYJ60AR2IKICCLOZAPINE TABLET, ORALLY DISINTEGRATING [MYLAN PHARMACEUTICALS INC.]6
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1CLOZAPINE TABLET, ORALLY DISINTEGRATING [MYLAN PHARMACEUTICALS INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLOZAPINE TABLET, ORALLY DISINTEGRATING [MYLAN PHARMACEUTICALS INC.]6
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCLOZAPINE TABLET, ORALLY DISINTEGRATING [MYLAN PHARMACEUTICALS INC.]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CLOZAPINE TABLET, ORALLY DISINTEGRATING [MYLAN PHARMACEUTICALS INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLOZAPINE TABLET, ORALLY DISINTEGRATING [MYLAN PHARMACEUTICALS INC.]6
MANNITOLINACTIVE INGREDIENT3OWL53L36ACLOZAPINE TABLET, ORALLY DISINTEGRATING [MYLAN PHARMACEUTICALS INC.]6
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BCLOZAPINE TABLET, ORALLY DISINTEGRATING [MYLAN PHARMACEUTICALS INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLOZAPINE TABLET, ORALLY DISINTEGRATING [MYLAN PHARMACEUTICALS INC.]6
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UICLOZAPINE TABLET, ORALLY DISINTEGRATING [MYLAN PHARMACEUTICALS INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-3813CLOZAPINE TABLET, ORALLY DISINTEGRATING [MYLAN PHARMACEUTICALS INC.]23Current NDC, Legacy NDC, 1 package rows20241127_9ae4b8e4-d8b1-4f01-bb4c-cd1cea90b219.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476177cloZAPine 100 MG Disintegrating Oral TabletPSN9ae4b8e4-d8b1-4f01-bb4c-cd1cea90b21926
1006801cloZAPine 150 MG Disintegrating Oral TabletPSN9ae4b8e4-d8b1-4f01-bb4c-cd1cea90b21926
996921cloZAPine 200 MG Disintegrating Oral TabletPSN9ae4b8e4-d8b1-4f01-bb4c-cd1cea90b21926
476179cloZAPine 25 MG Disintegrating Oral TabletPSN9ae4b8e4-d8b1-4f01-bb4c-cd1cea90b21926
476177clozapine 100 MG Disintegrating Oral TabletSCD9ae4b8e4-d8b1-4f01-bb4c-cd1cea90b21926
1006801clozapine 150 MG Disintegrating Oral TabletSCD9ae4b8e4-d8b1-4f01-bb4c-cd1cea90b21926
996921clozapine 200 MG Disintegrating Oral TabletSCD9ae4b8e4-d8b1-4f01-bb4c-cd1cea90b21926
476179clozapine 25 MG Disintegrating Oral TabletSCD9ae4b8e4-d8b1-4f01-bb4c-cd1cea90b21926

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-3813-0100378381301100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-3813-01) 2015-11-020000-00-00NoNoCurrent