FDA.reportPublic FDA data

Clozapine

Product NDC
0093-5417
11-digit product format
000935417
Labeler code
0093
Product ID
0093-5417_1b735bc2-6341-40af-8696-e61621d91ee8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clozapine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA090308
Marketing category
ANDA
Marketing start
2017-07-25
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
Rxcui476177, 476179, 721773, 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
0093-5417-01Clozapine100 in 1 BOTTLETABLET, ORALLY DISINTEGRATING10012
0093-5417-19Clozapine1 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING112
0093-5417-84Clozapine48 in 1 CARTONTABLET, ORALLY DISINTEGRATING4812

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-5417-01EA - Each0093-541756e4a342-add0-495c-b3da-cca3e1312f0812017-08-11
0093-5417-19EA - Each0093-5417e43f0ed9-60cd-4fa4-9f69-a3069e0c7af912017-08-11
0093-5417-84EA - Each0093-541700aafe06-4b01-4c53-87d4-780898d26fb012017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-5417CLOZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA, INC.]11Current NDC, Legacy NDC, 3 package rows20250309_6fccf4f7-2e30-4272-9800-225aaef20584.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476177cloZAPine 100 MG Disintegrating Oral TabletPSN6fccf4f7-2e30-4272-9800-225aaef2058412
721773cloZAPine 12.5 MG Disintegrating Oral TabletPSN6fccf4f7-2e30-4272-9800-225aaef2058412
1006801cloZAPine 150 MG Disintegrating Oral TabletPSN6fccf4f7-2e30-4272-9800-225aaef2058412
996921cloZAPine 200 MG Disintegrating Oral TabletPSN6fccf4f7-2e30-4272-9800-225aaef2058412
476179cloZAPine 25 MG Disintegrating Oral TabletPSN6fccf4f7-2e30-4272-9800-225aaef2058412
476177clozapine 100 MG Disintegrating Oral TabletSCD6fccf4f7-2e30-4272-9800-225aaef2058412
721773clozapine 12.5 MG Disintegrating Oral TabletSCD6fccf4f7-2e30-4272-9800-225aaef2058412
1006801clozapine 150 MG Disintegrating Oral TabletSCD6fccf4f7-2e30-4272-9800-225aaef2058412
996921clozapine 200 MG Disintegrating Oral TabletSCD6fccf4f7-2e30-4272-9800-225aaef2058412
476179clozapine 25 MG Disintegrating Oral TabletSCD6fccf4f7-2e30-4272-9800-225aaef2058412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-5417-0100093541701100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (0093-5417-01) 2017-07-250000-00-00NoNoCurrent
0093-5417-19000935417191 in 1 BLISTER PACKHistorical
0093-5417-840009354178448 BLISTER PACK in 1 CARTON (0093-5417-84) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0093-5417-19) 48 blister pack2017-07-250000-00-00NoNoCurrent