docetaxel

Generic: docetaxel anhydrous

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

Drug Facts

Product Profile

Brand Name docetaxel
Generic Name docetaxel anhydrous
Labeler hospira, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

docetaxel anhydrous 10 mg/mL

Manufacturer
Hospira, Inc.

Identifiers & Regulatory

Product NDC 0409-0016
Product ID 0409-0016_8156a5f8-7002-479d-a08d-3c68f92c1396
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022234
Listing Expiration 2026-12-31
Marketing Start 2022-01-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04090016
Hyphenated Format 0409-0016

Supplemental Identifiers

RxCUI
1093280 1860619
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 NDA022234 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (0409-0016-01) / 16 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

0409-0016-01 1 VIAL, MULTI-DOSE in 1 CARTON (0409-0016-01) / 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": "8156a5f8-7002-479d-a08d-3c68f92c1396", "openfda": {"nui": ["N0000175085", "N0000175592"], "unii": ["699121PHCA"], "rxcui": ["1093280", "1860619"], "spl_set_id": ["00c61d11-d6b7-4618-b6f6-2592dbcc8af7"], "pharm_class_pe": ["Microtubule Inhibition [PE]"], "pharm_class_epc": ["Microtubule Inhibitor [EPC]"], "manufacturer_name": ["Hospira, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (0409-0016-01)  / 16 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "0409-0016-01", "marketing_start_date": "20220110"}], "brand_name": "Docetaxel", "product_id": "0409-0016_8156a5f8-7002-479d-a08d-3c68f92c1396", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "0409-0016", "generic_name": "DOCETAXEL ANHYDROUS", "labeler_name": "Hospira, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Docetaxel", "active_ingredients": [{"name": "DOCETAXEL ANHYDROUS", "strength": "10 mg/mL"}], "application_number": "NDA022234", "marketing_category": "NDA", "marketing_start_date": "20220110", "listing_expiration_date": "20261231"}