Pemetrexed Injection
NDC Package 63759-3049-1

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

Package Information

Pemetrexed (pemetrexed disodium) injection is pemetrexed is used to treat certain types of cancer (such as lung cancer, mesothelioma). This formulation utilizes a injection delivery system. Marketed by Shilpa Medicare Limited, this product is identified by NDC 63759-3049 and is authorized under FDA application NDA215179.

Identification & Billing

NDC Package Code
63759-3049-1
Package Description
1 VIAL in 1 CARTON / 50 mL in 1 VIAL
Product Code
63759-3049
11-Digit Billing Format
63759304901
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Pemetrexed
Non-Proprietary Name
Pemetrexed Disodium
Substance Name
Pemetrexed Disodium Hemipentahydrate
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)
PEMETREXED DISODIUM HEMIPENTAHYDRATE 500 mg/50mL
Pharmacologic Class
Usage Information
Pemetrexed is used to treat certain types of cancer (such as lung cancer, mesothelioma). It is a chemotherapy drug that works by slowing or stopping the growth of cancer cells.

Regulatory & Marketing

Labeler Name
Shilpa Medicare Limited
Product Type
Human Prescription Drug
FDA Application #
NDA215179
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-01-2024
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 63759-3049-1 identifies a specific commercial package of 1 vial in 1 carton / 50 ml in 1 vial of Pemetrexed, a human prescription drug labeled by Shilpa Medicare Limited. This injection is formulated for intravenous use and contains pemetrexed disodium hemipentahydrate 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 Shilpa Medicare Limited on January 01, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Pemetrexed is used to treat certain types of cancer (such as lung cancer, mesothelioma). It is a chemotherapy drug that works by slowing or stopping the growth of cancer cells.

How is this Shilpa Medicare Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63759304901. 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 (5-4-1)
63759-3049-1
11-Digit CMS (5-4-2)
63759-3049-01

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