FDA.reportPublic FDA data

Clozapine

Product NDC
59651-261
11-digit product format
596510261
Labeler code
59651
Product ID
59651-261_5fe42ada-7ea2-4b77-bad5-93e1b1fb765d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clozapine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA212923
Marketing category
ANDA
Marketing start
2024-12-12
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
59651-261-01Clozapine100 in 1 BOTTLETABLET, ORALLY DISINTEGRATING1003
59651-261-48Clozapine6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING63
59651-261-48Clozapine8 in 1 CARTONTABLET, ORALLY DISINTEGRATING83

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-261-01EA - Each59651-261f9fcb294-8e3f-404a-96b4-416569d7895e12025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-261CLOZAPINE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]2Current NDC, 3 package rows20250303_caf2d4a6-2a23-4992-a807-560c4204afc4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476177cloZAPine 100 MG Disintegrating Oral TabletPSNcaf2d4a6-2a23-4992-a807-560c4204afc43
721773cloZAPine 12.5 MG Disintegrating Oral TabletPSNcaf2d4a6-2a23-4992-a807-560c4204afc43
1006801cloZAPine 150 MG Disintegrating Oral TabletPSNcaf2d4a6-2a23-4992-a807-560c4204afc43
996921cloZAPine 200 MG Disintegrating Oral TabletPSNcaf2d4a6-2a23-4992-a807-560c4204afc43
476179cloZAPine 25 MG Disintegrating Oral TabletPSNcaf2d4a6-2a23-4992-a807-560c4204afc43
476177clozapine 100 MG Disintegrating Oral TabletSCDcaf2d4a6-2a23-4992-a807-560c4204afc43
721773clozapine 12.5 MG Disintegrating Oral TabletSCDcaf2d4a6-2a23-4992-a807-560c4204afc43
1006801clozapine 150 MG Disintegrating Oral TabletSCDcaf2d4a6-2a23-4992-a807-560c4204afc43
996921clozapine 200 MG Disintegrating Oral TabletSCDcaf2d4a6-2a23-4992-a807-560c4204afc43
476179clozapine 25 MG Disintegrating Oral TabletSCDcaf2d4a6-2a23-4992-a807-560c4204afc43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-261-0159651026101100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (59651-261-01) 2024-12-12NoNoHistorical
59651-261-48596510261488 BLISTER PACK in 1 CARTON (59651-261-48) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK8 blister pack2024-12-12NoNoHistorical