docetaxel

Generic: docetaxel

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

Drug Facts

Product Profile

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

docetaxel 20 mg/mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-781
Product ID 67457-781_fea50522-6e4c-4ae0-81ac-53863693cc06
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208137
Listing Expiration 2026-12-31
Marketing Start 2019-06-18

Pharmacologic Class

Classes
microtubule inhibition [pe] microtubule inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457781
Hyphenated Format 67457-781

Supplemental Identifiers

RxCUI
1001405
UPC
0367457781082
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 ANDA208137 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (67457-781-08) / 8 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

67457-781-08 1 VIAL, MULTI-DOSE in 1 CARTON (67457-781-08) / 8 mL in 1 VIAL, MULTI-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": "fea50522-6e4c-4ae0-81ac-53863693cc06", "openfda": {"upc": ["0367457781082"], "unii": ["15H5577CQD"], "rxcui": ["1001405"], "spl_set_id": ["a6417655-9448-4886-ba03-f57f36bcbd14"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (67457-781-08)  / 8 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "67457-781-08", "marketing_start_date": "20190618"}], "brand_name": "Docetaxel", "product_id": "67457-781_fea50522-6e4c-4ae0-81ac-53863693cc06", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "67457-781", "generic_name": "Docetaxel", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Docetaxel", "active_ingredients": [{"name": "DOCETAXEL", "strength": "20 mg/mL"}], "application_number": "ANDA208137", "marketing_category": "ANDA", "marketing_start_date": "20190618", "listing_expiration_date": "20261231"}