Fusilev
NDC Package 68152-101-00

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Fusilev is a medication used to treat or prevent serious blood cell disorders (such as thrombocytopenia, neutropenia, anemia) caused by certain drugs (folic acid antagonists such as methotrexate, trimethoprim, pyrimethamine). Marketed by Acrotech Biopharma Llc, this product is identified by NDC 68152-101 and is authorized under FDA application NDA020140.

Identification & Billing

NDC Package Code
68152-101-00
Package Description
1 VIAL in 1 CARTON / 5 mL in 1 VIAL
Product Code
68152-101
11-Digit Billing Format
68152010100
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Fusilev
Dosage Form
-
Usage Information
This medication is used to treat or prevent serious blood cell disorders (such as thrombocytopenia, neutropenia, anemia) caused by certain drugs (folic acid antagonists such as methotrexate, trimethoprim, pyrimethamine). Some brands may also be used with a certain cancer drug (5-fluorouracil) to treat patients with colon cancer.

Regulatory & Marketing

Labeler Name
Acrotech Biopharma Llc
FDA Application #
NDA020140
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-15-2008
End Marketing Date
02-28-2019
Listing Expiration
02-28-2019
Exclude Flag
D
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 68152-101-00 identifies a specific commercial package of 1 vial in 1 carton / 5 ml in 1 vial of Fusilev, labeled by Acrotech Biopharma Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Acrotech Biopharma Llc on August 15, 2008. The current certification is valid through February 28, 2019.

What are the primary indications for this medication?

This medication is used to treat or prevent serious blood cell disorders (such as thrombocytopenia, neutropenia, anemia) caused by certain drugs (folic acid antagonists such as methotrexate, trimethoprim, pyrimethamine). Some brands may also be used with a certain cancer drug (5-fluorouracil) to treat patients with colon cancer.

How is this Acrotech Biopharma Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68152010100. 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)
68152-101-00
11-Digit CMS (5-4-2)
68152-0101-00

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