paclitaxel protein-bound particles (69097-398)

Drug Facts

Product Profile

Brand Name paclitaxel protein-bound particles

Generic Name paclitaxel protein-bound particles

Labeler cipla usa inc.

Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION

Routes

INTRAVENOUS

Active Ingredients

paclitaxel 100 mg/20mL

Manufacturer

Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-398

Product ID 69097-398_7dcacda6-4a5c-4840-8f8d-cbf7b30f3415

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA209657

Listing Expiration 2026-12-31

Marketing Start 2025-04-15

Pharmacologic Class

Established (EPC)

microtubule inhibitor [epc]

Physiologic Effect

microtubule inhibition [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69097398

Hyphenated Format 69097-398

Supplemental Identifiers

RxCUI

583214

UPC

0369097398781

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 (source: ndc)

Generic Name paclitaxel protein-bound particles (source: ndc)

Application Number ANDA209657 (source: ndc)

Routes

INTRAVENOUS

source: ndc

Resolved Composition

Strengths

100 mg/20mL

source: ndc

Packaging

1 VIAL, SINGLE-DOSE in 1 CARTON (69097-398-78) / 20 mL in 1 VIAL, SINGLE-DOSE

source: ndc

Packages (1)

69097-398-78 1 VIAL, SINGLE-DOSE in 1 CARTON (69097-398-78) / 20 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

paclitaxel (100 mg/20mL)

Linked Drug Pages (1)

Paclitaxel protein-bound particles ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["INTRAVENOUS"], "spl_id": "7dcacda6-4a5c-4840-8f8d-cbf7b30f3415", "openfda": {"nui": ["N0000175085", "N0000175592"], "upc": ["0369097398781"], "unii": ["P88XT4IS4D"], "rxcui": ["583214"], "spl_set_id": ["15eba86c-d9de-42e6-bc95-70ba4c015e72"], "pharm_class_pe": ["Microtubule Inhibition [PE]"], "pharm_class_epc": ["Microtubule Inhibitor [EPC]"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (69097-398-78)  / 20 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "69097-398-78", "marketing_start_date": "20250415"}], "brand_name": "Paclitaxel protein-bound particles", "product_id": "69097-398_7dcacda6-4a5c-4840-8f8d-cbf7b30f3415", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "69097-398", "generic_name": "Paclitaxel protein-bound particles", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paclitaxel protein-bound particles", "active_ingredients": [{"name": "PACLITAXEL", "strength": "100 mg/20mL"}], "application_number": "ANDA209657", "marketing_category": "ANDA", "marketing_start_date": "20250415", "listing_expiration_date": "20261231"}