docetaxel

Generic: docetaxel anhydrous

Labeler: ingenus pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name docetaxel
Generic Name docetaxel anhydrous
Labeler ingenus pharmaceuticals, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

docetaxel anhydrous 10 mg/mL

Manufacturer
Ingenus Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 50742-463
Product ID 50742-463_afea70f0-7856-4b96-8163-1e91c02453be
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207563
Listing Expiration 2026-12-31
Marketing Start 2017-09-07

Pharmacologic Class

Established (EPC)
microtubule inhibitor [epc]
Physiologic Effect
microtubule inhibition [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50742463
Hyphenated Format 50742-463

Supplemental Identifiers

RxCUI
1093280 1860619
UPC
0350742463169 0350742431083
UNII
699121PHCA
NUI
N0000175085 N0000175592

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 anhydrous (source: ndc)
Application Number ANDA207563 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (50742-463-16) / 16 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

50742-463-16 1 VIAL, MULTI-DOSE in 1 CARTON (50742-463-16) / 16 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

docetaxel anhydrous (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": "afea70f0-7856-4b96-8163-1e91c02453be", "openfda": {"nui": ["N0000175085", "N0000175592"], "upc": ["0350742463169", "0350742431083"], "unii": ["699121PHCA"], "rxcui": ["1093280", "1860619"], "spl_set_id": ["b17679e8-88c8-4b8d-bfae-246fab6eead9"], "pharm_class_pe": ["Microtubule Inhibition [PE]"], "pharm_class_epc": ["Microtubule Inhibitor [EPC]"], "manufacturer_name": ["Ingenus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (50742-463-16)  / 16 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "50742-463-16", "marketing_start_date": "20170907"}], "brand_name": "DOCETAXEL", "product_id": "50742-463_afea70f0-7856-4b96-8163-1e91c02453be", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "50742-463", "generic_name": "DOCETAXEL ANHYDROUS", "labeler_name": "Ingenus Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DOCETAXEL", "active_ingredients": [{"name": "DOCETAXEL ANHYDROUS", "strength": "10 mg/mL"}], "application_number": "ANDA207563", "marketing_category": "ANDA", "marketing_start_date": "20170907", "listing_expiration_date": "20261231"}