Humalog
NDC Package 54868-4381-0

11-digit billing NDC: 54868438100 · Billing unit: ML · 10 ML per package
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 inactivated by the FDA.

Humalog is mix75/25, a mixture of 75% insulin lispro protamine suspension and 25% insulin lispro injection, (rDNA origin), is indicated in the treatment of patients with diabetes mellitus for the control of hyperglycemia. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-4381 and is authorized under FDA application NDA021017.

Identification & Billing

NDC Package Code
54868-4381-0
Package Description
1 VIAL in 1 CARTON / 10 mL in 1 VIAL
Product Code
54868-4381
11-Digit Billing Format
54868438100
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
10 ML
RxNorm Crosswalk
  • RxCUI: 259111 - insulin lispro protamine / insulin lispro 75/25 Injectable Suspension
  • RxCUI: 259111 - insulin lispro 25 UNT/ML / insulin lispro protamine, human 75 UNT/ML Injectable Suspension
  • RxCUI: 259111 - insulin analog, lispro mixed 75/25 100 UNT/ML Injectable Suspension
  • RxCUI: 752388 - HumaLOG Mix 75/25 Injectable Suspension
  • RxCUI: 752388 - insulin lispro 25 UNT/ML / insulin lispro protamine, human 75 UNT/ML Injectable Suspension [Humalog Mix]

Clinical Specifications

Proprietary Name
Humalog Mix75/25
Dosage Form
-
Usage Information
Humalog Mix75/25, a mixture of 75% insulin lispro protamine suspension and 25% insulin lispro injection, (rDNA origin), is indicated in the treatment of patients with diabetes mellitus for the control of hyperglycemia. Humalog Mix75/25 has a more rapid onset of glucose–lowering activity compared with Humulin 70/30 while having a similar duration of action. This profile is achieved by combining the rapid onset of Humalog with the intermediate action of insulin lispro protamine suspension.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA021017
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-22-2005
Listing Expiration
12-31-2017
Exclude Flag
I
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 54868-4381-0 identifies a specific commercial package of 1 vial in 1 carton / 10 ml in 1 vial of Humalog Mix75/25, labeled by Physicians Total Care, Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 10 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 Physicians Total Care, Inc. on February 22, 2005. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868438100. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 10 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 (5-4-1)
54868-4381-0
11-Digit CMS (5-4-2)
54868-4381-00

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