FDA.reportPublic FDA data

CLOZAPINE - Food and Drug Administration

Manufacturer
Food and Drug Administration
Effective date
2025-08-12
Label type
Indexing - Product Concept
Version
5
Source
full-release
Hydrated at
2026-06-05 00:26:34

Label at a glance#

ProductCLOZAPINE
Active ingredientCLOZAPINE

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
CLOZAPINEJ60AR2IKICACTIB
CLOZAPINEJ60AR2IKICACTIB
CLOZAPINEJ60AR2IKICACTIB
CLOZAPINEJ60AR2IKICACTIB
CLOZAPINEJ60AR2IKICACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VERSACLOZCLOZAPINETruPharma LLC2592c9a8-fd74-4e0d-a895-b07b014cf3552026-09-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLOZAPINE
CLOZAPINECLOZAPINENorthStar Rx LLC61fe53d5-ed5c-4e45-9189-709d08d386cb2026-05-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CLOZAPINE
generic name: CLOZAPINE
CLOZAPINECLOZAPINECardinal Health 107, LLC7c748f8a-73ce-4bd3-aa30-9c66657f06ec2026-04-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CLOZAPINE
generic name: CLOZAPINE
ClozapineCLOZAPINEMylan Pharmaceuticals Inc.883b5d43-0339-7dc1-f775-93791fb9b9782026-04-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clozapine
generic name: CLOZAPINE
ClozapineCLOZAPINESafecor Health, LLC09231d80-6343-4a34-bd5b-100c547fd3c92026-03-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clozapine
generic name: CLOZAPINE
ClozapineCLOZAPINESafecor Health LLC0fa59238-f0a6-4d00-9d8d-df2a43718fc12026-03-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clozapine
generic name: CLOZAPINE
CLOZAPINECLOZAPINEMajor Pharmaceuticals9db7aefb-f607-4158-a310-181e631bc6482026-01-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CLOZAPINE
generic name: CLOZAPINE
CLOZAPINECLOZAPINEAurobindo Pharma Limited5021d643-32d2-4167-b5d8-90870e68a7872025-12-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CLOZAPINE
generic name: CLOZAPINE
ClozapineCLOZAPINEMylan Institutional Inc.d5c8a456-6f3c-4963-b321-4ed746f690e42025-11-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clozapine
generic name: CLOZAPINE
ClozapineCLOZAPINEAccord Healthcare Inc.25c0c6d5-f7b0-48e4-e054-00144ff8d46c2025-10-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clozapine
generic name: CLOZAPINE
ClozapineCLOZAPINEAmerican Health Packagingd36c298b-7292-46e0-898f-43d3e11c3cf42025-09-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clozapine
generic name: CLOZAPINE
ClozapineCLOZAPINEMylan Pharmaceuticals Inc.9ae4b8e4-d8b1-4f01-bb4c-cd1cea90b2192025-08-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clozapine
generic name: CLOZAPINE
ClozapineCLOZAPINEMylan Institutional Inc.976be6e3-a9db-49c6-9b02-1ab168cf17b12025-07-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clozapine
generic name: CLOZAPINE
ClozapineCLOZAPINETeva Pharmaceuticals USA, Inc.6fccf4f7-2e30-4272-9800-225aaef205842025-06-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clozapine
generic name: CLOZAPINE
ClozarilCLOZAPINEHLS Therapeutics (USA), Inc.90876802-0e3a-44c9-9ff7-1754dfbe736a2025-06-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLOZAPINE
ClozapineCLOZAPINEAurobindo Pharma Limitedcaf2d4a6-2a23-4992-a807-560c4204afc42025-06-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clozapine
generic name: CLOZAPINE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.