MedPath

Avastin

These highlights do not include all the information needed to use AVASTIN safely and effectively. See full prescribing information for AVASTIN. AVASTIN (bevacizumab) injection, for intravenous use Initial U.S. Approval: 2004

Approved
Approval ID

939b5d1f-9fb2-4499-80ef-0607aa6b114e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 23, 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.

bevacizumab

PRODUCT DETAILS

NDC Product Code50242-060
Application NumberBLA125085
Marketing CategoryC73585
Route of AdministrationINTRAVENOUS
Effective DateSeptember 23, 2022
Generic Namebevacizumab

INGREDIENTS (6)

SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 23.2 mg in 4 mL
Code: 593YOG76RN
Classification: IACT
BEVACIZUMABActive
Quantity: 100 mg in 4 mL
Code: 2S9ZZM9Q9V
Classification: ACTIB
POLYSORBATE 20Inactive
Quantity: 1.6 mg in 4 mL
Code: 7T1F30V5YH
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Quantity: 4.8 mg in 4 mL
Code: 22ADO53M6F
Classification: IACT
TREHALOSE DIHYDRATEInactive
Quantity: 240 mg in 4 mL
Code: 7YIN7J07X4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

bevacizumab

PRODUCT DETAILS

NDC Product Code50242-061
Application NumberBLA125085
Marketing CategoryC73585
Route of AdministrationINTRAVENOUS
Effective DateSeptember 23, 2022
Generic Namebevacizumab

INGREDIENTS (6)

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
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 92.8 mg in 16 mL
Code: 593YOG76RN
Classification: IACT
POLYSORBATE 20Inactive
Quantity: 6.4 mg in 16 mL
Code: 7T1F30V5YH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BEVACIZUMABActive
Quantity: 400 mg in 16 mL
Code: 2S9ZZM9Q9V
Classification: ACTIB

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Avastin - FDA Drug Approval Details