FDA.reportPublic FDA data

Clozaril

Product NDC
69809-0126
11-digit product format
698090126
Labeler code
69809
Product ID
69809-0126_14601465-eda2-4063-b606-cb6cfcaaca3d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clozapine
Dosage form
TABLET
Route
ORAL
Labeler
HLS Therapeutics (USA), Inc.
Application
NDA019758
Marketing category
NDA
Marketing start
2016-05-06
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
Clozaril
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOZAPINE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ60AR2IKIC
Rxcui104775, 104776, 197535, 197536

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69809-0126-52020-07-22C16284748780-1ab0e2407-3629-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use CLOZARIL safely and effectively. See full prescribing information for CLOZARIL. CLOZARIL ® (clozapine) tablets, for oral use Initial U.S. Approval: 1989

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69809-0126-5Clozaril100 in 1 BOTTLETABLET10021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69809-0126-5EA - Each69809-01265be67460-5839-4e32-ab46-181d162778dc12017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69809-0126CLOZARIL (CLOZAPINE) TABLET [HLS THERAPEUTICS (USA), INC.]19Current NDC, Legacy NDC, 1 package rows20250327_90876802-0e3a-44c9-9ff7-1754dfbe736a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197535cloZAPine 100 MG Oral TabletPSN90876802-0e3a-44c9-9ff7-1754dfbe736a21
197536cloZAPine 25 MG Oral TabletPSN90876802-0e3a-44c9-9ff7-1754dfbe736a21
104776Clozaril 100 MG Oral TabletPSN90876802-0e3a-44c9-9ff7-1754dfbe736a21
104775Clozaril 25 MG Oral TabletPSN90876802-0e3a-44c9-9ff7-1754dfbe736a21
104776clozapine 100 MG Oral Tablet [Clozaril]SBD90876802-0e3a-44c9-9ff7-1754dfbe736a21
104775clozapine 25 MG Oral Tablet [Clozaril]SBD90876802-0e3a-44c9-9ff7-1754dfbe736a21
197535clozapine 100 MG Oral TabletSCD90876802-0e3a-44c9-9ff7-1754dfbe736a21
197536clozapine 25 MG Oral TabletSCD90876802-0e3a-44c9-9ff7-1754dfbe736a21
104776Clozaril 100 MG Oral TabletSY90876802-0e3a-44c9-9ff7-1754dfbe736a21
104775Clozaril 25 MG Oral TabletSY90876802-0e3a-44c9-9ff7-1754dfbe736a21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69809-0126-569809012605100 TABLET in 1 BOTTLE (69809-0126-5) 100 tablet2016-05-060000-00-00NoNoCurrent