Ifosfamide Injection, Solution
NDC Package 71288-180-20

11-digit billing NDC: 71288018020
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Ifosfamide injection is indicated for use  in adults in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. . This formulation utilizes a injection, solution delivery system. Marketed by Meitheal Pharmaceutical Inc., this product is identified by NDC 71288-180 and is authorized under FDA application ANDA076657.

Identification & Billing

NDC Package Code
71288-180-20
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-DOSE
Product Code
71288-180
11-Digit Billing Format
71288018020

Clinical Specifications

Proprietary Name
Ifosfamide
Non-Proprietary Name
Ifosfamide
Substance Name
Ifosfamide
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)
IFOSFAMIDE 1 g/20mL
Pharmacologic Class
Usage Information
Ifosfamide Injection is indicated for use  in adults in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. 

Regulatory & Marketing

Labeler Name
Meitheal Pharmaceutical Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA076657
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-26-2007
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 71288-180-20 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 20 ml in 1 vial, single-dose of Ifosfamide, a human prescription drug labeled by Meitheal Pharmaceutical Inc.. This injection, solution is formulated for intravenous use and contains ifosfamide 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 Meitheal Pharmaceutical Inc. on July 26, 2007. The current certification is valid through December 31, 2027.

How is this Meitheal Pharmaceutical Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71288018020. 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)
71288-180-20
11-Digit CMS (5-4-2)
71288-0180-20

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