CLOZAPINE

Product NDC
0904-7406
11-digit product format
009047406
Labeler code
0904
Product ID
0904-7406_3f7b2119-695f-4b57-b505-b07a8f9cc065
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLOZAPINE
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA206433
Marketing category
ANDA
Marketing start
2016-11-29
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
0904-7406-61CLOZAPINE1 in 1 BLISTER PACKTABLET15
0904-7406-61CLOZAPINE100 in 1 CARTONTABLET1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7406-61EA - Each0904-74066c20adab-3122-4fa8-8ec5-ca61768b423112024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7406CLOZAPINE TABLET [MAJOR PHARMACEUTICALS]4Current NDC, 2 package rows20250402_9db7aefb-f607-4158-a310-181e631bc648.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197535cloZAPine 100 MG Oral TabletPSN9db7aefb-f607-4158-a310-181e631bc6485
309374cloZAPine 200 MG Oral TabletPSN9db7aefb-f607-4158-a310-181e631bc6485
197536cloZAPine 25 MG Oral TabletPSN9db7aefb-f607-4158-a310-181e631bc6485
429212cloZAPine 50 MG Oral TabletPSN9db7aefb-f607-4158-a310-181e631bc6485
197535clozapine 100 MG Oral TabletSCD9db7aefb-f607-4158-a310-181e631bc6485
309374clozapine 200 MG Oral TabletSCD9db7aefb-f607-4158-a310-181e631bc6485
197536clozapine 25 MG Oral TabletSCD9db7aefb-f607-4158-a310-181e631bc6485
429212clozapine 50 MG Oral TabletSCD9db7aefb-f607-4158-a310-181e631bc6485

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7406-6100904740661100 BLISTER PACK in 1 CARTON (0904-7406-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2016-11-29NoNoHistorical