Paclitaxel Injection
NDC Package 46708-620-05

11-digit billing NDC: 46708062005
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Paclitaxel injection is uSP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. This formulation utilizes a injection delivery system. Marketed by Alembic Pharmaceuticals Limited, this product is identified by NDC 46708-620 and is authorized under FDA application ANDA216874.

Identification & Billing

NDC Package Code
46708-620-05
Package Description
1 VIAL, MULTI-DOSE in 1 CARTON / 5 mL in 1 VIAL, MULTI-DOSE
Product Code
46708-620
11-Digit Billing Format
46708062005
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Paclitaxel
Non-Proprietary Name
Paclitaxel
Substance Name
Paclitaxel
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)
PACLITAXEL 6 mg/mL
Pharmacologic Class
Usage Information
Paclitaxel Injection, USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, Paclitaxel Injection, USP is indicated in combination with cisplatin.Paclitaxel Injection, USP is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor-negative tumors (see CLINICAL STUDIES, Breast Carcinoma).Paclitaxel Injection, USP is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.Paclitaxel Injection, USP, in combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy.Paclitaxel Injection, USP is indicated for the second-line treatment of AIDS-related Kaposi's sarcoma.

Regulatory & Marketing

Labeler Name
Alembic Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA216874
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-20-2022
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 46708-620-05 identifies a specific commercial package of 1 vial, multi-dose in 1 carton / 5 ml in 1 vial, multi-dose of Paclitaxel, a human prescription drug labeled by Alembic Pharmaceuticals Limited. This injection 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 Alembic Pharmaceuticals Limited on October 20, 2022. The current certification is valid through December 31, 2026.

How is this Alembic Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46708062005. 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)
46708-620-05
11-Digit CMS (5-4-2)
46708-0620-05

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