NDC 0075-8004

TAXOTERE

Docetaxel

TAXOTERE is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Sanofi-aventis U.s. Llc. The primary component is Docetaxel.

• Product ID: 0075-8004_519e570f-c38f-45eb-bdd4-e373691f3d79
• NDC: 0075-8004
• Product Type: Human Prescription Drug
• Proprietary Name: TAXOTERE
• Generic Name: Docetaxel
• Dosage Form: Injection, Solution, Concentrate
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2010-08-02
• Marketing End Date: 2021-04-30
• Marketing Category: NDA / NDA
• Application Number: NDA020449
• Labeler Name: Sanofi-Aventis U.S. LLC
• Substance Name: DOCETAXEL
• Active Ingredient Strength: 80 mg/4mL
• Pharm Classes: Microtubule Inhibition [PE],Microtubule Inhibitor [EPC]
• NDC Exclude Flag: N

Packaging

NDC 0075-8004-04

1 VIAL, GLASS in 1 CARTON (0075-8004-04) > 4 mL in 1 VIAL, GLASS

• Marketing Start Date: 2010-08-02
• Marketing End Date: 2021-04-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0075-8004-04 [00075800404]

TAXOTERE INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: NDA
• Application Number: NDA020449
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2010-08-02
• Marketing End Date: 2021-04-30

Drug Details

Active Ingredients

Ingredient	Strength
DOCETAXEL	80 mg/4mL

OpenFDA Data

• SPL SET ID: 45e6dce4-92e2-4ad1-bf11-bbcefb753636
• Manufacturer:
  • sanofi-aventis U.S. LLC
• UNII:
  • 15H5577CQD
• RxNorm Concept Unique ID - RxCUI:
  • 1860485
  • 1860486
  • 1860480
  • 1860482

Pharmacological Class

• Microtubule Inhibition [PE]
• Microtubule Inhibitor [EPC]

NDC Crossover Matching brand name "TAXOTERE" or generic name "Docetaxel"

NDC	Brand Name	Generic Name
0075-8003	TAXOTERE	Docetaxel
0075-8004	TAXOTERE	Docetaxel
0143-9204	Docetaxel	Docetaxel
0143-9205	Docetaxel	Docetaxel
0409-0365	Docetaxel	DOCETAXEL
0409-0366	Docetaxel	DOCETAXEL
0409-0367	Docetaxel	DOCETAXEL
0409-0368	Docetaxel	DOCETAXEL
0409-4235	Docetaxel	DOCETAXEL
0409-5068	Docetaxel	DOCETAXEL
0955-1020	Docetaxel	Docetaxel
0955-1021	Docetaxel	Docetaxel