CLOZAPINE

Product NDC
63629-2362
11-digit product format
636292362
Labeler code
63629
Product ID
63629-2362_2a13d25a-9e81-4e2d-b110-d8c390b9caba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLOZAPINE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075713
Marketing category
ANDA
Marketing start
2017-11-08
Substance
CLOZAPINE
Active strength
200 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
CLOZAPINE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ60AR2IKIC
Rxcui309374

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
63629-2362-1CLOZAPINE100 in 1 BOTTLETABLET100104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2362-1EA - Each63629-2362eca6b7e3-771b-4176-92ab-46f36250fecb12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2362CLOZAPINE TABLET [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 1 package rows20240514_f060a13b-5846-4615-8d43-fa60653a9658.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309374cloZAPine 200 MG Oral TabletPSNf060a13b-5846-4615-8d43-fa60653a9658104
309374clozapine 200 MG Oral TabletSCDf060a13b-5846-4615-8d43-fa60653a9658104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2362-163629236201100 TABLET in 1 BOTTLE (63629-2362-1) 100 tablet2018-02-100000-00-00NoNoCurrent