Phesgo
These highlights do not include all the information needed to use PHESGO safely and effectively. See full prescribing information for PHESGO. PHESGO (pertuzumab, trastuzumab, and hyaluronidase-zzxf) injection, for subcutaneous use Initial U.S. Approval: 2020
Approved
Approval ID
27dd5e6b-72cd-458d-a015-cf4dab5800da
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 16, 2022
Manufacturers
FDA
Genentech, Inc.
DUNS: 080129000
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
pertuzumab, trastuzumab, and hyaluronidase-zzxf
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50242-260
Application NumberBLA761170
Product Classification
M
Marketing Category
C73585
G
Generic Name
pertuzumab, trastuzumab, and hyaluronidase-zzxf
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 16, 2022
FDA Product Classification
INGREDIENTS (10)
PERTUZUMABActive
Quantity: 600 mg in 10 mL
Code: K16AIQ8CTM
Classification: ACTIB
TRASTUZUMABActive
Quantity: 600 mg in 10 mL
Code: P188ANX8CK
Classification: ACTIB
HYALURONIDASE (HUMAN RECOMBINANT)Active
Quantity: 20000 U in 10 mL
Code: 743QUY4VD8
Classification: ACTIB
HISTIDINE MONOHYDROCHLORIDEInactive
Code: 1D5Q932XM6
Classification: IACT
HISTIDINEInactive
Code: 4QD397987E
Classification: IACT
TREHALOSE DIHYDRATEInactive
Code: 7YIN7J07X4
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
METHIONINEInactive
Code: AE28F7PNPL
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
pertuzumab, trastuzumab, and hyaluronidase-zzxf
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50242-245
Application NumberBLA761170
Product Classification
M
Marketing Category
C73585
G
Generic Name
pertuzumab, trastuzumab, and hyaluronidase-zzxf
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 16, 2022
FDA Product Classification
INGREDIENTS (10)
TRASTUZUMABActive
Quantity: 600 mg in 15 mL
Code: P188ANX8CK
Classification: ACTIB
HISTIDINEInactive
Code: 4QD397987E
Classification: IACT
HISTIDINE MONOHYDROCHLORIDEInactive
Code: 1D5Q932XM6
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
METHIONINEInactive
Code: AE28F7PNPL
Classification: IACT
TREHALOSE DIHYDRATEInactive
Code: 7YIN7J07X4
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
PERTUZUMABActive
Quantity: 1200 mg in 15 mL
Code: K16AIQ8CTM
Classification: ACTIB
HYALURONIDASE (HUMAN RECOMBINANT)Active
Quantity: 30000 U in 15 mL
Code: 743QUY4VD8
Classification: ACTIB
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT