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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 use Initial U.S. Approval: 1996

Approved
Approval ID

3a49c281-8cfd-4698-a9df-90ba800058ef

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 4, 2023

Manufacturers
FDA

Alembic Pharmaceuticals Inc.

DUNS: 079288842

Products 1

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 Code62332-678
Application NumberANDA215744
Product Classification
M
Marketing Category
C73584
G
Generic Name
Docetaxel
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 4, 2023
FDA Product Classification

INGREDIENTS (5)

DOCETAXEL ANHYDROUSActive
Quantity: 10 mg in 1 mL
Code: 699121PHCA
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POLYETHYLENE GLYCOL 300Inactive
Code: 5655G9Y8AQ
Classification: IACT

Drug Labeling Information

BOXED WARNING SECTION

LOINC: 34066-1Updated: 9/4/2023

**WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY

REACTIONS, and FLUID RETENTION**

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Docetaxel - FDA Drug Approval Details