docetaxel

Generic: docetaxel

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

Drug Facts

Product Profile

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

docetaxel 20 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9204
Product ID 0143-9204_5e524fd3-4dc2-4a16-b069-7790c57fcb72
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204490
Listing Expiration 2026-12-31
Marketing Start 2021-01-14

Pharmacologic Class

Classes
microtubule inhibition [pe] microtubule inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439204
Hyphenated Format 0143-9204

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 ANDA204490 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (0143-9204-01) / 1 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

0143-9204-01 1 VIAL, GLASS in 1 CARTON (0143-9204-01) / 1 mL in 1 VIAL, GLASS

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": "5e524fd3-4dc2-4a16-b069-7790c57fcb72", "openfda": {"unii": ["15H5577CQD"], "rxcui": ["1860480", "1860485"], "spl_set_id": ["ff7fb2c2-97a7-4716-a269-925ca30cf0f1"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (0143-9204-01)  / 1 mL in 1 VIAL, GLASS", "package_ndc": "0143-9204-01", "marketing_start_date": "20210114"}], "brand_name": "Docetaxel", "product_id": "0143-9204_5e524fd3-4dc2-4a16-b069-7790c57fcb72", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "0143-9204", "generic_name": "Docetaxel", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Docetaxel", "active_ingredients": [{"name": "DOCETAXEL", "strength": "20 mg/mL"}], "application_number": "ANDA204490", "marketing_category": "ANDA", "marketing_start_date": "20210114", "listing_expiration_date": "20261231"}