Vegzelma
These highlights do not include all the information needed to use VEGZELMA safely and effectively. See full prescribing information for VEGZELMA. VEGZELMA (bevacizumab-adcd) injection, for intravenous use Initial U.S. Approval: 2022 VEGZELMA (bevacizumab-adcd) is biosimilar to AVASTIN (bevacizumab).
Approved
Approval ID
4cdcccda-7b9a-49d0-ac50-f4605a3c0ebe
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 22, 2023
Manufacturers
FDA
CELLTRION USA, Inc.
DUNS: 116587378
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
bevacizumab-adcd
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72606-012
Application NumberBLA761268
Product Classification
M
Marketing Category
C73585
G
Generic Name
bevacizumab-adcd
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 22, 2023
FDA Product Classification
INGREDIENTS (6)
BEVACIZUMABActive
Quantity: 400 mg in 16 mL
Code: 2S9ZZM9Q9V
Classification: ACTIB
TREHALOSE DIHYDRATEInactive
Quantity: 960 mg in 16 mL
Code: 7YIN7J07X4
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Quantity: 19.2 mg in 16 mL
Code: 22ADO53M6F
Classification: IACT
POLYSORBATE 20Inactive
Quantity: 6.4 mg in 16 mL
Code: 7T1F30V5YH
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 92.8 mg in 16 mL
Code: 593YOG76RN
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
bevacizumab-adcd
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72606-011
Application NumberBLA761268
Product Classification
M
Marketing Category
C73585
G
Generic Name
bevacizumab-adcd
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 22, 2023
FDA Product Classification
INGREDIENTS (6)
BEVACIZUMABActive
Quantity: 100 mg in 4 mL
Code: 2S9ZZM9Q9V
Classification: ACTIB
TREHALOSE DIHYDRATEInactive
Quantity: 240 mg in 4 mL
Code: 7YIN7J07X4
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Quantity: 4.8 mg in 4 mL
Code: 22ADO53M6F
Classification: IACT
POLYSORBATE 20Inactive
Quantity: 1.6 mg in 4 mL
Code: 7T1F30V5YH
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 23.2 mg in 4 mL
Code: 593YOG76RN
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT