OGIVRI
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 2017
Approved
Approval ID
b6465b44-a6dd-f99c-d009-6851cf05169c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 24, 2024
Manufacturers
FDA
Biocon Biologics Inc.
DUNS: 117609395
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
trastuzumab-dkst
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code83257-003
Application NumberBLA761074
Product Classification
M
Marketing Category
C73585
G
Generic Name
trastuzumab-dkst
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 19, 2024
FDA Product Classification
INGREDIENTS (5)
TRASTUZUMABActive
Quantity: 420 mg in 20 mL
Code: P188ANX8CK
Classification: ACTIB
HISTIDINE MONOHYDROCHLORIDEInactive
Quantity: 9.4 mg in 20 mL
Code: 1D5Q932XM6
Classification: IACT
HISTIDINEInactive
Quantity: 6.0 mg in 20 mL
Code: 4QD397987E
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Quantity: 94.1 mg in 20 mL
Code: G2M7P15E5P
Classification: IACT
SORBITOLInactive
Quantity: 322.6 mg in 20 mL
Code: 506T60A25R
Classification: IACT
trastuzumab-dkst
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code83257-001
Application NumberBLA761074
Product Classification
M
Marketing Category
C73585
G
Generic Name
trastuzumab-dkst
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 19, 2024
FDA Product Classification
INGREDIENTS (5)
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
HISTIDINEInactive
Code: 4QD397987E
Classification: IACT
HISTIDINE MONOHYDROCHLORIDEInactive
Code: 1D5Q932XM6
Classification: IACT
TRASTUZUMABActive
Quantity: 150 mg in 7.4 mL
Code: P188ANX8CK
Classification: ACTIB
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
trastuzumab-dkst
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code83257-004
Application NumberBLA761074
Product Classification
M
Marketing Category
C73585
G
Generic Name
trastuzumab-dkst
Product Specifications
Effective DateJanuary 19, 2024
FDA Product Classification