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

Generic: paclitaxel

Labeler: bluepoint laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

paclitaxel 100 mg/20mL

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-651
Product ID 68001-651_3c3af5f5-c5d8-a6a1-e063-6294a90a68e7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216355
Listing Expiration 2026-12-31
Marketing Start 2025-07-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68001651
Hyphenated Format 68001-651

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 ANDA216355 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/20mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (68001-651-37) / 20 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

68001-651-37 1 VIAL, SINGLE-USE in 1 CARTON (68001-651-37) / 20 mL in 1 VIAL, SINGLE-USE

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": "3c3af5f5-c5d8-a6a1-e063-6294a90a68e7", "openfda": {"nui": ["N0000175085", "N0000175592"], "unii": ["P88XT4IS4D"], "rxcui": ["583214"], "spl_set_id": ["36d4a2ed-4b34-4b06-e063-6394a90acc86"], "pharm_class_pe": ["Microtubule Inhibition [PE]"], "pharm_class_epc": ["Microtubule Inhibitor [EPC]"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (68001-651-37)  / 20 mL in 1 VIAL, SINGLE-USE", "package_ndc": "68001-651-37", "marketing_start_date": "20250718"}], "brand_name": "Paclitaxel protein-bound particles for injectable suspension (albumin-bound)", "product_id": "68001-651_3c3af5f5-c5d8-a6a1-e063-6294a90a68e7", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "68001-651", "generic_name": "Paclitaxel", "labeler_name": "BluePoint Laboratories", "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": "ANDA216355", "marketing_category": "ANDA", "marketing_start_date": "20250718", "listing_expiration_date": "20261231"}