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Bortezomib

These highlights do not include all the information needed to use BORTEZOMIB INJECTION safely and effectively.See full prescribing information for BORTEZOMIB INJECTION.                                                                                                                                                              BORTEZOMIB injection, for intravenous use Initial U.S. Approval: 2003

Approved
Approval ID

c40e6a28-d577-43d4-bca6-bef28da1d580

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 22, 2021

Manufacturers
FDA

MAIA Pharmaceuticals, Inc.

DUNS: 079211845

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

bortezomib

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70511-162
Application NumberNDA215331
Product Classification
M
Marketing Category
C73594
G
Generic Name
bortezomib
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 10, 2022
FDA Product Classification

INGREDIENTS (6)

BORTEZOMIBActive
Quantity: 2.5 mg in 1 1
Code: 69G8BD63PP
Classification: ACTIB
MANNITOLInactive
Quantity: 25 mg in 1 1
Code: 3OWL53L36A
Classification: IACT
SODIUM ACETATEInactive
Quantity: 0.82 mg in 1 1
Code: 4550K0SC9B
Classification: IACT
DIMETHYL SULFOXIDEInactive
Quantity: 22 mg in 1 1
Code: YOW8V9698H
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT

bortezomib

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70511-161
Application NumberNDA215331
Product Classification
M
Marketing Category
C73594
G
Generic Name
bortezomib
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 10, 2022
FDA Product Classification

INGREDIENTS (6)

BORTEZOMIBActive
Quantity: 1 mg in 1 1
Code: 69G8BD63PP
Classification: ACTIB
SODIUM ACETATEInactive
Quantity: 0.82 mg in 1 1
Code: 4550K0SC9B
Classification: IACT
DIMETHYL SULFOXIDEInactive
Quantity: 20 mg in 1 1
Code: YOW8V9698H
Classification: IACT
MANNITOLInactive
Quantity: 10 mg in 1 1
Code: 3OWL53L36A
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

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Bortezomib - FDA Drug Approval Details