abraxane

Generic: paclitaxel

Labeler: abraxis bioscience, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name abraxane
Generic Name paclitaxel
Labeler abraxis bioscience, llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Routes
INTRAVENOUS
Active Ingredients

paclitaxel 100 mg/20mL

Manufacturer
Abraxis BioScience, LLC

Identifiers & Regulatory

Product NDC 68817-134
Product ID 68817-134_25a98542-1909-490d-b162-6e36d3997d8a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021660
Listing Expiration 2026-12-31
Marketing Start 2005-02-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68817134
Hyphenated Format 68817-134

Supplemental Identifiers

RxCUI
583214 583218
UPC
0368817134500
UNII
P88XT4IS4D
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 abraxane (source: ndc)
Generic Name paclitaxel (source: ndc)
Application Number NDA021660 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/20mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (68817-134-50) / 20 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

68817-134-50 1 VIAL, SINGLE-USE in 1 CARTON (68817-134-50) / 20 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

paclitaxel (100 mg/20mL)

Linked Drug Pages (1)

ABRAXANE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "25a98542-1909-490d-b162-6e36d3997d8a", "openfda": {"nui": ["N0000175085", "N0000175592"], "upc": ["0368817134500"], "unii": ["P88XT4IS4D"], "rxcui": ["583214", "583218"], "spl_set_id": ["24d10449-2936-4cd3-b7db-a7683db721e4"], "pharm_class_pe": ["Microtubule Inhibition [PE]"], "pharm_class_epc": ["Microtubule Inhibitor [EPC]"], "manufacturer_name": ["Abraxis BioScience, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (68817-134-50)  / 20 mL in 1 VIAL, SINGLE-USE", "package_ndc": "68817-134-50", "marketing_start_date": "20050210"}], "brand_name": "ABRAXANE", "product_id": "68817-134_25a98542-1909-490d-b162-6e36d3997d8a", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "68817-134", "generic_name": "Paclitaxel", "labeler_name": "Abraxis BioScience, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ABRAXANE", "active_ingredients": [{"name": "PACLITAXEL", "strength": "100 mg/20mL"}], "application_number": "NDA021660", "marketing_category": "NDA", "marketing_start_date": "20050210", "listing_expiration_date": "20261231"}