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

Generic: paclitaxel

Labeler: meitheal pharmaceuticals inc.
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 meitheal pharmaceuticals inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Routes
INTRAVENOUS
Active Ingredients

paclitaxel 100 mg/20mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-183
Product ID 71288-183_ab2be690-a801-46c1-a254-213c3893fc24
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216355
Listing Expiration 2026-12-31
Marketing Start 2025-05-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288183
Hyphenated Format 71288-183

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 (71288-183-50) / 20 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

71288-183-50 1 VIAL, SINGLE-USE in 1 CARTON (71288-183-50) / 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": "ab2be690-a801-46c1-a254-213c3893fc24", "openfda": {"nui": ["N0000175085", "N0000175592"], "unii": ["P88XT4IS4D"], "rxcui": ["583214"], "spl_set_id": ["31e893aa-8d9e-4576-8614-eb2fe772bde4"], "pharm_class_pe": ["Microtubule Inhibition [PE]"], "pharm_class_epc": ["Microtubule Inhibitor [EPC]"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (71288-183-50)  / 20 mL in 1 VIAL, SINGLE-USE", "package_ndc": "71288-183-50", "marketing_start_date": "20250515"}], "brand_name": "Paclitaxel protein-bound particles for injectable suspension (albumin-bound)", "product_id": "71288-183_ab2be690-a801-46c1-a254-213c3893fc24", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "71288-183", "generic_name": "Paclitaxel", "labeler_name": "Meitheal Pharmaceuticals Inc.", "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": "20250515", "listing_expiration_date": "20261231"}