Herceptin Hylecta
These highlights do not include all the information needed to use HERCEPTIN HYLECTA safely and effectively. See full prescribing information for HERCEPTIN HYLECTA. HERCEPTIN HYLECTA (trastuzumab and hyaluronidase-oysk) injection, for subcutaneous use Initial U.S. Approval: 2019
Approved
Approval ID
ebf30894-41cf-480c-8bc3-56f592a13813
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 19, 2020
Manufacturers
FDA
Genentech, Inc.
DUNS: 080129000
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Trastuzumab and hyaluronidase-oysk
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50242-077
Application NumberBLA761106
Product Classification
M
Marketing Category
C73585
G
Generic Name
Trastuzumab and hyaluronidase-oysk
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateOctober 19, 2020
FDA Product Classification
INGREDIENTS (8)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TRASTUZUMABActive
Quantity: 600 mg in 5 mL
Code: P188ANX8CK
Classification: ACTIB
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Quantity: 18.35 mg in 5 mL
Code: X573657P6P
Classification: IACT
HISTIDINEInactive
Quantity: 1.95 mg in 5 mL
Code: 4QD397987E
Classification: IACT
TREHALOSE DIHYDRATEInactive
Quantity: 397.25 mg in 5 mL
Code: 7YIN7J07X4
Classification: IACT
POLYSORBATE 20Inactive
Quantity: 2 mg in 5 mL
Code: 7T1F30V5YH
Classification: IACT
METHIONINEInactive
Quantity: 7.45 mg in 5 mL
Code: AE28F7PNPL
Classification: IACT
HYALURONIDASE (HUMAN RECOMBINANT)Active
Quantity: 10000 U in 5 mL
Code: 743QUY4VD8
Classification: ACTIB