FDA.reportPublic FDA data

Clozapine

Product NDC
60687-404
11-digit product format
606870404
Labeler code
60687
Product ID
60687-404_3de71656-5df7-240a-e063-6294a90a303a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clozapine
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA206433
Marketing category
ANDA
Marketing start
2019-01-02
Substance
CLOZAPINE
Active strength
25 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
CLOZAPINE25 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
60687-404-01Clozapine100 in 1 BOX, UNIT-DOSETABLET1007
60687-404-11Clozapine1 in 1 BLISTER PACKTABLET17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-404-01EA - Each60687-4046cd8a36a-35a5-4084-b961-7fca23e9dc8712019-01-24
60687-404-11EA - Each60687-40456ca2b96-cb14-4112-94e3-461f0079e85d12019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-404CLOZAPINE TABLET [AMERICAN HEALTH PACKAGING]6Current NDC, Legacy NDC, 2 package rows20241109_d36c298b-7292-46e0-898f-43d3e11c3cf4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197535cloZAPine 100 MG Oral TabletPSNd36c298b-7292-46e0-898f-43d3e11c3cf47
309374cloZAPine 200 MG Oral TabletPSNd36c298b-7292-46e0-898f-43d3e11c3cf47
197536cloZAPine 25 MG Oral TabletPSNd36c298b-7292-46e0-898f-43d3e11c3cf47
429212cloZAPine 50 MG Oral TabletPSNd36c298b-7292-46e0-898f-43d3e11c3cf47
197535clozapine 100 MG Oral TabletSCDd36c298b-7292-46e0-898f-43d3e11c3cf47
309374clozapine 200 MG Oral TabletSCDd36c298b-7292-46e0-898f-43d3e11c3cf47
197536clozapine 25 MG Oral TabletSCDd36c298b-7292-46e0-898f-43d3e11c3cf47
429212clozapine 50 MG Oral TabletSCDd36c298b-7292-46e0-898f-43d3e11c3cf47

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-404-0160687040401100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-404-01) / 1 TABLET in 1 BLISTER PACK (60687-404-11) 100 blister pack2019-01-020000-00-00NoNoCurrent
60687-404-11606870404111 in 1 BLISTER PACKHistorical