docetaxel

Generic: docetaxel

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

Drug Facts

Product Profile

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

docetaxel 20 mg/mL

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 45963-734
Product ID 45963-734_0bc8d3b7-f15e-4dbf-b51f-8baaa93b0e61
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA203551
Listing Expiration 2026-12-31
Marketing Start 2014-09-01

Pharmacologic Class

Classes
microtubule inhibition [pe] microtubule inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45963734
Hyphenated Format 45963-734

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 NDA203551 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (45963-734-54) / 1 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

45963-734-54 1 VIAL, GLASS in 1 CARTON (45963-734-54) / 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": "0bc8d3b7-f15e-4dbf-b51f-8baaa93b0e61", "openfda": {"unii": ["15H5577CQD"], "rxcui": ["1860480", "1860485"], "spl_set_id": ["2c806400-5fdc-4398-8475-37f700b3191f"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (45963-734-54)  / 1 mL in 1 VIAL, GLASS", "package_ndc": "45963-734-54", "marketing_start_date": "20140901"}], "brand_name": "Docetaxel", "product_id": "45963-734_0bc8d3b7-f15e-4dbf-b51f-8baaa93b0e61", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "45963-734", "generic_name": "Docetaxel", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Docetaxel", "active_ingredients": [{"name": "DOCETAXEL", "strength": "20 mg/mL"}], "application_number": "NDA203551", "marketing_category": "NDA", "marketing_start_date": "20140901", "listing_expiration_date": "20261231"}