docetaxel

Generic: docetaxel

Labeler: hospira, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name docetaxel
Generic Name docetaxel
Labeler hospira, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

docetaxel 20 mg/mL

Manufacturer
Hospira, Inc.

Identifiers & Regulatory

Product NDC 0409-0368
Product ID 0409-0368_297f1202-b539-41ee-bf52-4b9b04dd3a60
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022234
Listing Expiration 2026-12-31
Marketing Start 2018-01-09

Pharmacologic Class

Classes
microtubule inhibition [pe] microtubule inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04090368
Hyphenated Format 0409-0368

Supplemental Identifiers

RxCUI
1001405 1860480
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 NDA022234 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (0409-0368-01) / 8 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

0409-0368-01 1 VIAL, MULTI-DOSE in 1 CARTON (0409-0368-01) / 8 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

docetaxel (20 mg/mL)

Linked Drug Pages (1)

Docetaxel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "297f1202-b539-41ee-bf52-4b9b04dd3a60", "openfda": {"unii": ["15H5577CQD"], "rxcui": ["1001405", "1860480"], "spl_set_id": ["3104aab1-cd6e-4ad2-8e0a-286a0c5d1940"], "manufacturer_name": ["Hospira, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (0409-0368-01)  / 8 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "0409-0368-01", "marketing_start_date": "20180109"}], "brand_name": "Docetaxel", "product_id": "0409-0368_297f1202-b539-41ee-bf52-4b9b04dd3a60", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "0409-0368", "generic_name": "DOCETAXEL", "labeler_name": "Hospira, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Docetaxel", "active_ingredients": [{"name": "DOCETAXEL", "strength": "20 mg/mL"}], "application_number": "NDA022234", "marketing_category": "NDA", "marketing_start_date": "20180109", "listing_expiration_date": "20261231"}