Docetaxel
These highlights do not include all the information needed to use DOCETAXEL safely and effectively. See full prescribing information for DOCETAXEL. DOCETAXEL injection, for intravenous use Initial U.S. Approval: 1996
Approved
Approval ID
dd0ca36d-1f54-4568-8d19-a7152addcd52
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 7, 2023
Manufacturers
FDA
Winthrop U.S, a business of sanofi-aventis U.S. LLC
DUNS: 824676584
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 Code0955-1020
Application NumberNDA020449
Product Classification
M
Marketing Category
C73605
G
Generic Name
Docetaxel
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 7, 2023
FDA Product Classification
INGREDIENTS (3)
POLYSORBATE 80Inactive
Quantity: 0.54 g in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
ALCOHOLInactive
Quantity: 0.395 g in 1 mL
Code: 3K9958V90M
Classification: IACT
DOCETAXELActive
Quantity: 20 mg in 1 mL
Code: 15H5577CQD
Classification: ACTIM
Docetaxel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0955-1021
Application NumberNDA020449
Product Classification
M
Marketing Category
C73605
G
Generic Name
Docetaxel
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 7, 2023
FDA Product Classification
INGREDIENTS (3)
POLYSORBATE 80Inactive
Quantity: 2.16 g in 4 mL
Code: 6OZP39ZG8H
Classification: IACT
DOCETAXELActive
Quantity: 80 mg in 4 mL
Code: 15H5577CQD
Classification: ACTIM
ALCOHOLInactive
Quantity: 1.58 g in 4 mL
Code: 3K9958V90M
Classification: IACT
Docetaxel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0955-1022
Application NumberNDA020449
Product Classification
M
Marketing Category
C73605
G
Generic Name
Docetaxel
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 7, 2023
FDA Product Classification
INGREDIENTS (3)
ALCOHOLInactive
Quantity: 3.16 g in 8 mL
Code: 3K9958V90M
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 4.32 g in 8 mL
Code: 6OZP39ZG8H
Classification: IACT
DOCETAXELActive
Quantity: 160 mg in 8 mL
Code: 15H5577CQD
Classification: ACTIM