Docetaxel
These highlights do not include all the information needed to use DOCETAXEL INJECTION safely and effectively. See full prescribing information for DOCETAXEL INJECTION. DOCETAXEL INJECTION, for intravenous useInitial U.S. Approval: 1996
Approved
Approval ID
0e0f06bd-d190-45da-be8b-062e8de01970
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 21, 2023
Manufacturers
FDA
Baxter Healthcare Corporation
DUNS: 005083209
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
docetaxel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43066-001
Application NumberNDA201525
Product Classification
M
Marketing Category
C73594
G
Generic Name
docetaxel
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 20, 2017
FDA Product Classification
INGREDIENTS (5)
DOCETAXELActive
Quantity: 10 mg in 1 mL
Code: 15H5577CQD
Classification: ACTIM
POLYSORBATE 80Inactive
Quantity: 80 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
ALCOHOLInactive
Quantity: 275.9 mg in 1 mL
Code: 3K9958V90M
Classification: IACT
POLYETHYLENE GLYCOL 300Inactive
Quantity: 648 mg in 1 mL
Code: 5655G9Y8AQ
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Quantity: 4 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
docetaxel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43066-010
Application NumberNDA201525
Product Classification
M
Marketing Category
C73594
G
Generic Name
docetaxel
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 20, 2017
FDA Product Classification
INGREDIENTS (5)
DOCETAXELActive
Quantity: 10 mg in 1 mL
Code: 15H5577CQD
Classification: ACTIM
POLYSORBATE 80Inactive
Quantity: 80 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
ALCOHOLInactive
Quantity: 275.9 mg in 1 mL
Code: 3K9958V90M
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Quantity: 4 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
POLYETHYLENE GLYCOL 300Inactive
Quantity: 648 mg in 1 mL
Code: 5655G9Y8AQ
Classification: IACT
docetaxel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43066-006
Application NumberNDA201525
Product Classification
M
Marketing Category
C73594
G
Generic Name
docetaxel
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 20, 2017
FDA Product Classification
INGREDIENTS (5)
POLYSORBATE 80Inactive
Quantity: 80 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
ALCOHOLInactive
Quantity: 275.9 mg in 1 mL
Code: 3K9958V90M
Classification: IACT
POLYETHYLENE GLYCOL 300Inactive
Quantity: 648 mg in 1 mL
Code: 5655G9Y8AQ
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Quantity: 4 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
DOCETAXELActive
Quantity: 10 mg in 1 mL
Code: 15H5577CQD
Classification: ACTIM