docetaxel

Generic: docetaxel

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

Drug Facts

Product Profile

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

docetaxel 10 mg/mL

Manufacturer
Sandoz Inc.

Identifiers & Regulatory

Product NDC 66758-050
Product ID 66758-050_4142deb5-9110-4cb8-8319-8a9f1cd04647
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA201525
Listing Expiration 2026-12-31
Marketing Start 2011-06-29

Pharmacologic Class

Classes
microtubule inhibition [pe] microtubule inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66758050
Hyphenated Format 66758-050

Supplemental Identifiers

RxCUI
1093280
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 NDA201525 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (66758-050-01) / 2 mL in 1 VIAL, MULTI-DOSE
  • 1 VIAL, MULTI-DOSE in 1 CARTON (66758-050-02) / 8 mL in 1 VIAL, MULTI-DOSE
  • 1 VIAL, MULTI-DOSE in 1 CARTON (66758-050-03) / 16 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (3)

66758-050-01 1 VIAL, MULTI-DOSE in 1 CARTON (66758-050-01) / 2 mL in 1 VIAL, MULTI-DOSE 66758-050-02 1 VIAL, MULTI-DOSE in 1 CARTON (66758-050-02) / 8 mL in 1 VIAL, MULTI-DOSE 66758-050-03 1 VIAL, MULTI-DOSE in 1 CARTON (66758-050-03) / 16 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

docetaxel (10 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": "4142deb5-9110-4cb8-8319-8a9f1cd04647", "openfda": {"unii": ["15H5577CQD"], "rxcui": ["1093280"], "spl_set_id": ["e03d1378-6889-43d5-a34c-f96132cffa88"], "manufacturer_name": ["Sandoz Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (66758-050-01)  / 2 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "66758-050-01", "marketing_start_date": "20110629"}, {"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (66758-050-02)  / 8 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "66758-050-02", "marketing_start_date": "20110629"}, {"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (66758-050-03)  / 16 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "66758-050-03", "marketing_start_date": "20110629"}], "brand_name": "Docetaxel", "product_id": "66758-050_4142deb5-9110-4cb8-8319-8a9f1cd04647", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "66758-050", "generic_name": "docetaxel", "labeler_name": "Sandoz Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Docetaxel", "active_ingredients": [{"name": "DOCETAXEL", "strength": "10 mg/mL"}], "application_number": "NDA201525", "marketing_category": "NDA", "marketing_start_date": "20110629", "listing_expiration_date": "20261231"}