docetaxel

Generic: docetaxel

Labeler: sanofi-aventis u.s. llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name docetaxel
Generic Name docetaxel
Labeler sanofi-aventis u.s. llc
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

docetaxel 80 mg/4mL

Manufacturer
Sanofi-Aventis U.S. LLC

Identifiers & Regulatory

Product NDC 0955-1021
Product ID 0955-1021_7c9667b2-3981-4256-a6a5-0c862549f837
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020449
Listing Expiration 2026-12-31
Marketing Start 2010-10-21

Pharmacologic Class

Classes
microtubule inhibition [pe] microtubule inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09551021
Hyphenated Format 0955-1021

Supplemental Identifiers

RxCUI
1860480 1860485 1861411
UNII
15H5577CQD

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name docetaxel (source: ndc)
Generic Name docetaxel (source: ndc)
Application Number NDA020449 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 80 mg/4mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (0955-1021-04) / 4 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

0955-1021-04 1 VIAL, GLASS in 1 CARTON (0955-1021-04) / 4 mL in 1 VIAL, GLASS

Ingredients (1)

docetaxel (80 mg/4mL)

Linked Drug Pages (1)

Docetaxel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "7c9667b2-3981-4256-a6a5-0c862549f837", "openfda": {"unii": ["15H5577CQD"], "rxcui": ["1860480", "1860485", "1861411"], "spl_set_id": ["dd0ca36d-1f54-4568-8d19-a7152addcd52"], "manufacturer_name": ["Sanofi-Aventis U.S. LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (0955-1021-04)  / 4 mL in 1 VIAL, GLASS", "package_ndc": "0955-1021-04", "marketing_start_date": "20101021"}], "brand_name": "Docetaxel", "product_id": "0955-1021_7c9667b2-3981-4256-a6a5-0c862549f837", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "0955-1021", "generic_name": "Docetaxel", "labeler_name": "Sanofi-Aventis U.S. LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Docetaxel", "active_ingredients": [{"name": "DOCETAXEL", "strength": "80 mg/4mL"}], "application_number": "NDA020449", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20101021", "listing_expiration_date": "20261231"}