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Clozaril

These 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 useInitial U.S. Approval: 1989

Approved
Approval ID

90876802-0e3a-44c9-9ff7-1754dfbe736a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 23, 2023

Manufacturers
FDA

HLS Therapeutics (USA), Inc.

DUNS: 079808066

Products 4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

clozapine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69809-0130
Application NumberNDA019758
Product Classification
M
Marketing Category
C73594
G
Generic Name
clozapine
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 11, 2021
FDA Product Classification

INGREDIENTS (7)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CLOZAPINEActive
Quantity: 50 mg in 1 1
Code: J60AR2IKIC
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT

clozapine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69809-0126
Application NumberNDA019758
Product Classification
M
Marketing Category
C73594
G
Generic Name
clozapine
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 11, 2021
FDA Product Classification

INGREDIENTS (7)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
CLOZAPINEActive
Quantity: 25 mg in 1 1
Code: J60AR2IKIC
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT

clozapine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69809-0127
Application NumberNDA019758
Product Classification
M
Marketing Category
C73594
G
Generic Name
clozapine
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 11, 2021
FDA Product Classification

INGREDIENTS (7)

CLOZAPINEActive
Quantity: 100 mg in 1 1
Code: J60AR2IKIC
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT

clozapine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69809-0135
Application NumberNDA019758
Product Classification
M
Marketing Category
C73594
G
Generic Name
clozapine
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 11, 2021
FDA Product Classification

INGREDIENTS (7)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CLOZAPINEActive
Quantity: 200 mg in 1 1
Code: J60AR2IKIC
Classification: ACTIB

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Clozaril - FDA Drug Approval Details