Docetaxel Injection
NDC Package 68083-401-01

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

Package Information

Docetaxel injection is a medication used to treat cancer (such as breast, lung, prostate, stomach, and head/neck cancer). This formulation utilizes a injection delivery system. Marketed by Gland Pharma Limited, this product is identified by NDC 68083-401 and is authorized under FDA application ANDA213510.

Identification & Billing

NDC Package Code
68083-401-01
Package Description
1 VIAL, MULTI-DOSE in 1 CARTON / 16 mL in 1 VIAL, MULTI-DOSE
Product Code
68083-401
11-Digit Billing Format
68083040101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Docetaxel
Non-Proprietary Name
Docetaxel
Substance Name
Docetaxel Anhydrous
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
DOCETAXEL ANHYDROUS 10 mg/mL
Pharmacologic Class
Usage Information
This medication is used to treat cancer (such as breast, lung, prostate, stomach, and head/neck cancer). Docetaxel is a member of a family of drugs called taxanes. This drug works by slowing cell growth.

Regulatory & Marketing

Labeler Name
Gland Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA213510
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-01-2021
Listing Expiration
12-31-2026
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 68083-401-01 identifies a specific commercial package of 1 vial, multi-dose in 1 carton / 16 ml in 1 vial, multi-dose of Docetaxel, a human prescription drug labeled by Gland Pharma Limited. This injection is formulated for intravenous use and contains docetaxel anhydrous 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 Gland Pharma Limited on July 01, 2021. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat cancer (such as breast, lung, prostate, stomach, and head/neck cancer). Docetaxel is a member of a family of drugs called taxanes. This drug works by slowing cell growth.

How is this Gland Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68083040101. 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)
68083-401-01
11-Digit CMS (5-4-2)
68083-0401-01

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