Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Biocon Biologics Limited
Biocon Biologics Inc.
650501997
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
OGIVRI
Product Details
NDC Product Code
83257-003Application Number
BLA761074Marketing Category
BLA (C73585)Route of Administration
INTRAVENOUSEffective Date
January 19, 2024TrastuzumabActive
Code: P188ANX8CKClass: ACTIBQuantity: 420 mg in 20 mL
HISTIDINE MONOHYDROCHLORIDEInactive
Code: 1D5Q932XM6Class: IACTQuantity: 9.4 mg in 20 mL
HISTIDINEInactive
Code: 4QD397987EClass: IACTQuantity: 6.0 mg in 20 mL
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACTQuantity: 94.1 mg in 20 mL
SORBITOLInactive
Code: 506T60A25RClass: IACTQuantity: 322.6 mg in 20 mL
OGIVRI
Product Details
NDC Product Code
83257-001Application Number
BLA761074Marketing Category
BLA (C73585)Route of Administration
INTRAVENOUSEffective Date
January 19, 2024SORBITOLInactive
Code: 506T60A25RClass: IACT
HISTIDINEInactive
Code: 4QD397987EClass: IACT
HISTIDINE MONOHYDROCHLORIDEInactive
Code: 1D5Q932XM6Class: IACT
TrastuzumabActive
Code: P188ANX8CKClass: ACTIBQuantity: 150 mg in 7.4 mL
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
OGIVRI
Product Details
NDC Product Code
83257-004Application Number
BLA761074Marketing Category
BLA (C73585)Effective Date
January 19, 2024