Pemetrexed Injection, Powder, Lyophilized, For Solution
NDC Package 63323-621-00

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, powder, lyophilized, for solution delivery system. Marketed by Fresenius Kabi Usa, Llc, this product is identified by NDC 63323-621 and is authorized under FDA application ANDA090384.

Identification & Billing

NDC Package Code
63323-621-00
Package Description
1 VIAL, SINGLE-USE in 1 CARTON / 30 mL in 1 VIAL, SINGLE-USE
Product Code
63323-621
11-Digit Billing Format
63323062100
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Pemetrexed
Non-Proprietary Name
Pemetrexed Disodium
Substance Name
Pemetrexed Disodium
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
PEMETREXED DISODIUM 750 mg/30mL
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
Fresenius Kabi Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA090384
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-25-2022
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 63323-621-00 identifies a specific commercial package of 1 vial, single-use in 1 carton / 30 ml in 1 vial, single-use of Pemetrexed, a human prescription drug labeled by Fresenius Kabi Usa, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains pemetrexed disodium 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 Fresenius Kabi Usa, Llc on May 25, 2022. 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 Fresenius Kabi Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63323062100. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
63323-621-00
11-Digit CMS (5-4-2)
63323-0621-00

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