docetaxel

Generic: docetaxel

Labeler: meitheal pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

docetaxel 20 mg/mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-133
Product ID 71288-133_bf235693-ce1a-4f89-b33a-8aaf93efb275
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213768
Listing Expiration 2026-12-31
Marketing Start 2025-05-13

Pharmacologic Class

Classes
microtubule inhibition [pe] microtubule inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288133
Hyphenated Format 71288-133

Supplemental Identifiers

RxCUI
1860480 1860485
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 ANDA213768 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-133-01) / 1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

71288-133-01 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-133-01) / 1 mL in 1 VIAL, SINGLE-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": "bf235693-ce1a-4f89-b33a-8aaf93efb275", "openfda": {"unii": ["15H5577CQD"], "rxcui": ["1860480", "1860485"], "spl_set_id": ["f970e352-3d43-4cc4-a859-503ec37b6e22"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-133-01)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "71288-133-01", "marketing_start_date": "20250513"}], "brand_name": "Docetaxel", "product_id": "71288-133_bf235693-ce1a-4f89-b33a-8aaf93efb275", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "71288-133", "generic_name": "Docetaxel", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Docetaxel", "active_ingredients": [{"name": "DOCETAXEL", "strength": "20 mg/mL"}], "application_number": "ANDA213768", "marketing_category": "ANDA", "marketing_start_date": "20250513", "listing_expiration_date": "20261231"}