Paclitaxel 100mg Per Vial Injection, Powder, Lyophilized, For Suspension
NDC Package 76282-768-09

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Paclitaxel 100mg Per Vial (paclitaxel protein-bound particles) injection is paclitaxel is used to treat various types of cancer. This formulation utilizes a injection, powder, lyophilized, for suspension delivery system. Marketed by Exelan Pharmaceuticals Inc., this product is identified by NDC 76282-768 and is authorized under FDA application ANDA209657.

Identification & Billing

NDC Package Code
76282-768-09
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-DOSE
Product Code
76282-768
11-Digit Billing Format
76282076809

Clinical Specifications

Proprietary Name
Paclitaxel 100mg Per Vial
Non-Proprietary Name
Paclitaxel Protein-bound Particles
Substance Name
Paclitaxel
Dosage Form
Injection, Powder, Lyophilized, For Suspension - A liquid preparation, intended for parenteral use that contains solids suspended in a suitable fluid medium and conforms in all respects to the requirements for Sterile Suspensions; the medicinal agents intended for the suspension are prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
PACLITAXEL 100 mg/20mL
Pharmacologic Class
Usage Information
Paclitaxel is used to treat various types of cancer. It is a cancer chemotherapy drug that works by slowing or stopping cancer cell growth.

Regulatory & Marketing

Labeler Name
Exelan Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA209657
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-11-2026
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 76282-768-09 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 20 ml in 1 vial, single-dose of Paclitaxel 100mg Per Vial, a human prescription drug labeled by Exelan Pharmaceuticals Inc.. This injection, powder, lyophilized, for suspension is formulated for intravenous use and contains paclitaxel as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Exelan Pharmaceuticals Inc. on August 11, 2026. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Paclitaxel is used to treat various types of cancer. It is a cancer chemotherapy drug that works by slowing or stopping cancer cell growth.

How is this Exelan Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76282076809. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
76282-768-09
11-Digit CMS (5-4-2)
76282-0768-09

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.