Paclitaxel Injection, Solution
NDC Package 69339-229-50

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

Package Information

Paclitaxel injection is paclitaxel is used to treat various types of cancer. This formulation utilizes a injection, solution delivery system. Marketed by Natco Pharma Usa Llc, this product is identified by NDC 69339-229 and is authorized under FDA application ANDA091540.

Identification & Billing

NDC Package Code
69339-229-50
Package Description
1 VIAL, MULTI-DOSE in 1 CARTON / 50 mL in 1 VIAL, MULTI-DOSE
Product Code
69339-229
11-Digit Billing Format
69339022950
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Paclitaxel
Non-Proprietary Name
Paclitaxel
Substance Name
Paclitaxel
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
PACLITAXEL 6 mg/mL
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
Natco Pharma Usa Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA091540
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-07-2024
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 69339-229-50 identifies a specific commercial package of 1 vial, multi-dose in 1 carton / 50 ml in 1 vial, multi-dose of Paclitaxel, a human prescription drug labeled by Natco Pharma Usa Llc. This injection, solution 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 Natco Pharma Usa Llc on November 07, 2024. 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 Natco Pharma Usa Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69339022950. 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)
69339-229-50
11-Digit CMS (5-4-2)
69339-0229-50

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