docetaxel

Generic: docetaxel

Labeler: accord healthcare inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

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

docetaxel anhydrous 20 mg/mL

Manufacturer
Accord Healthcare Inc.

Identifiers & Regulatory

Product NDC 16729-267
Product ID 16729-267_1fbda3cb-1ba1-490d-e063-6294a90a6777
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA201195
Listing Expiration 2026-12-31
Marketing Start 2013-05-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16729267
Hyphenated Format 16729-267

Supplemental Identifiers

RxCUI
1001405
UPC
0316729267656
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 (source: ndc)
Application Number NDA201195 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (16729-267-63) / 1 mL in 1 VIAL, MULTI-DOSE
  • 1 VIAL, MULTI-DOSE in 1 CARTON (16729-267-64) / 4 mL in 1 VIAL, MULTI-DOSE
  • 1 VIAL, MULTI-DOSE in 1 CARTON (16729-267-65) / 8 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (3)

16729-267-63 1 VIAL, MULTI-DOSE in 1 CARTON (16729-267-63) / 1 mL in 1 VIAL, MULTI-DOSE 16729-267-64 1 VIAL, MULTI-DOSE in 1 CARTON (16729-267-64) / 4 mL in 1 VIAL, MULTI-DOSE 16729-267-65 1 VIAL, MULTI-DOSE in 1 CARTON (16729-267-65) / 8 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

docetaxel anhydrous (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": "1fbda3cb-1ba1-490d-e063-6294a90a6777", "openfda": {"nui": ["N0000175085", "N0000175592"], "upc": ["0316729267656"], "unii": ["699121PHCA"], "rxcui": ["1001405"], "spl_set_id": ["f59f7811-70b7-4c44-99f7-4f4fdce3ed22"], "pharm_class_pe": ["Microtubule Inhibition [PE]"], "pharm_class_epc": ["Microtubule Inhibitor [EPC]"], "manufacturer_name": ["Accord Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (16729-267-63)  / 1 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "16729-267-63", "marketing_start_date": "20131022"}, {"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (16729-267-64)  / 4 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "16729-267-64", "marketing_start_date": "20130802"}, {"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (16729-267-65)  / 8 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "16729-267-65", "marketing_start_date": "20130530"}], "brand_name": "DOCETAXEL", "product_id": "16729-267_1fbda3cb-1ba1-490d-e063-6294a90a6777", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "16729-267", "generic_name": "docetaxel", "labeler_name": "Accord Healthcare Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DOCETAXEL", "active_ingredients": [{"name": "DOCETAXEL ANHYDROUS", "strength": "20 mg/mL"}], "application_number": "NDA201195", "marketing_category": "NDA", "marketing_start_date": "20130530", "listing_expiration_date": "20261231"}