paclitaxel protein-bound particles for injectable suspension (albumin-bound)

Generic: paclitaxel

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name paclitaxel protein-bound particles for injectable suspension (albumin-bound)
Generic Name paclitaxel
Labeler upsher-smith laboratories, llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Routes
INTRAVENOUS
Active Ingredients

paclitaxel 100 mg/20mL

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 24979-710
Product ID 24979-710_72be83ed-81a8-4d5d-abf9-9154e481d840
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021660
Listing Expiration 2026-12-31
Marketing Start 2022-04-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 24979710
Hyphenated Format 24979-710

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 for injectable suspension (albumin-bound) (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
  • 16 HOW SUPPLIED/STORAGE AND HANDLING Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is a white to yellow, sterile lyophilized powder supplied as: NDC : 24979-710-51 100 mg of paclitaxel in a single-dose vial, individually packaged in a carton. Store the vials in original cartons at 20°C to 25°C (68°F to 77°F). Retain in the original package to protect from bright light. Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1
  • PRINCIPAL DISPLAY PANEL - 100 mg Vial NDC 24979-710-51 Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) 100 mg per vial Single Use Vial Discard any unused portion. For Intravenous Use Only Rx only DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS. PRINCIPAL DISPLAY PLAN - 100mg Vial
  • PRINCIPAL DISPLAY PANEL - 100 mg Vial NDC 24979-710-51 Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) 100 mg per vial Single Use Vial Discard any unused portion. For Intravenous Use Only Rx only DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS. PRINCIPAL DISPLAY PANEL - 100 mg Vial
  • PRINCIPAL DISPLAY PANEL - 100 mg Vial Carton NDC 24979-710-51 Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) 100 mg per vial Single Use Vial Discard any unused portion. For Intravenous Use Only Rx only DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS. PRINCIPAL DISPLAY PANEL - 100 mg Vial Carton
  • Package/Label Display Panel PRINCIPAL DISPLAY PANEL - 100 mg Vial Carton NDC 24979-710-51 Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) 100 mg per vial Single Use Vial Discard any unused portion. For Intravenous Use Only Rx only DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS. PRINCIPAL DISPLAY PANEL - 100 mg Vial Carton
source: label

Packages (0)

No package records.

Ingredients (1)

paclitaxel (100 mg/20mL)

Linked Drug Pages (1)

Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "72be83ed-81a8-4d5d-abf9-9154e481d840", "openfda": {"nui": ["N0000175085", "N0000175592"], "unii": ["P88XT4IS4D"], "rxcui": ["583214"], "spl_set_id": ["1f41135d-3da4-45b2-9462-6482256fa728"], "pharm_class_pe": ["Microtubule Inhibition [PE]"], "pharm_class_epc": ["Microtubule Inhibitor [EPC]"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound)", "product_id": "24979-710_72be83ed-81a8-4d5d-abf9-9154e481d840", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "24979-710", "generic_name": "Paclitaxel", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound)", "active_ingredients": [{"name": "PACLITAXEL", "strength": "100 mg/20mL"}], "application_number": "NDA021660", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20220401", "listing_expiration_date": "20261231"}