docetaxel

Generic: docetaxel anhydrous

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

docetaxel anhydrous 10 mg/mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-533
Product ID 67457-533_aa6fbb17-6b11-4cc2-9798-edf1e4befd47
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208859
Listing Expiration 2026-12-31
Marketing Start 2018-09-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457533
Hyphenated Format 67457-533

Supplemental Identifiers

RxCUI
1093280 1860619
UPC
0367457533162 0367457532080
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 ANDA208859 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (67457-533-16) / 16 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

67457-533-16 1 VIAL, MULTI-DOSE in 1 CARTON (67457-533-16) / 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": "aa6fbb17-6b11-4cc2-9798-edf1e4befd47", "openfda": {"nui": ["N0000175085", "N0000175592"], "upc": ["0367457533162", "0367457532080"], "unii": ["699121PHCA"], "rxcui": ["1093280", "1860619"], "spl_set_id": ["2fb017fd-e55e-43ef-9024-07f2d412b37b"], "pharm_class_pe": ["Microtubule Inhibition [PE]"], "pharm_class_epc": ["Microtubule Inhibitor [EPC]"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (67457-533-16)  / 16 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "67457-533-16", "marketing_start_date": "20180905"}], "brand_name": "Docetaxel", "product_id": "67457-533_aa6fbb17-6b11-4cc2-9798-edf1e4befd47", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "67457-533", "generic_name": "DOCETAXEL ANHYDROUS", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Docetaxel", "active_ingredients": [{"name": "DOCETAXEL ANHYDROUS", "strength": "10 mg/mL"}], "application_number": "ANDA208859", "marketing_category": "ANDA", "marketing_start_date": "20180905", "listing_expiration_date": "20261231"}