paclitaxel protein bound particles albumin bound

Generic: paclitaxel

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

Drug Facts

Product Profile

Brand Name paclitaxel protein bound particles albumin bound
Generic Name paclitaxel
Labeler american regent, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Routes
INTRAVENOUS
Active Ingredients

paclitaxel 100 mg/20mL

Manufacturer
American Regent, Inc.

Identifiers & Regulatory

Product NDC 0517-4300
Product ID 0517-4300_5db1c7ab-35c2-4764-b1ae-33f44560883b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA211875
Listing Expiration 2026-12-31
Marketing Start 2023-05-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05174300
Hyphenated Format 0517-4300

Supplemental Identifiers

RxCUI
583214
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 paclitaxel protein bound particles albumin bound (source: ndc)
Generic Name paclitaxel (source: ndc)
Application Number NDA211875 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/20mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (0517-4300-01) / 20 mL in 1 VIAL
source: ndc

Packages (1)

0517-4300-01 1 VIAL in 1 CARTON (0517-4300-01) / 20 mL in 1 VIAL

Ingredients (1)

paclitaxel (100 mg/20mL)

Linked Drug Pages (1)

PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "5db1c7ab-35c2-4764-b1ae-33f44560883b", "openfda": {"nui": ["N0000175085", "N0000175592"], "unii": ["P88XT4IS4D"], "rxcui": ["583214"], "spl_set_id": ["f06d1bb3-83f1-4d84-8004-4c6681ad8a5a"], "pharm_class_pe": ["Microtubule Inhibition [PE]"], "pharm_class_epc": ["Microtubule Inhibitor [EPC]"], "manufacturer_name": ["American Regent, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (0517-4300-01)  / 20 mL in 1 VIAL", "package_ndc": "0517-4300-01", "marketing_start_date": "20230502"}], "brand_name": "PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND", "product_id": "0517-4300_5db1c7ab-35c2-4764-b1ae-33f44560883b", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "0517-4300", "generic_name": "Paclitaxel", "labeler_name": "American Regent, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND", "active_ingredients": [{"name": "PACLITAXEL", "strength": "100 mg/20mL"}], "application_number": "NDA211875", "marketing_category": "NDA", "marketing_start_date": "20230502", "listing_expiration_date": "20261231"}