Humulin N
NDC Package 54868-1429-1

11-digit billing NDC: 54868142901 · 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.

Humulin N is iNSTRUCTIONS FOR INSULIN VIAL USENEVER SHARE NEEDLES AND SYRINGES.Correct Syringe TypeDoses of insulin are measured in units. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-1429 and is authorized under FDA application NDA018781.

Identification & Billing

NDC Package Code
54868-1429-1
Package Description
1 VIAL in 1 CARTON / 10 mL in 1 VIAL
Product Code
54868-1429
11-Digit Billing Format
54868142901
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: 311026 - HumuLIN N 100 UNT/ML Injectable Suspension
  • RxCUI: 311026 - insulin isophane, human 100 UNT/ML Injectable Suspension [Humulin N]
  • RxCUI: 311026 - Humulin N 100 UNT/ML Injectable Suspension
  • RxCUI: 311028 - insulin isophane (NPH), human 100 UNT/mL Injectable Suspension
  • RxCUI: 311028 - insulin isophane, human 100 UNT/ML Injectable Suspension

Clinical Specifications

Proprietary Name
Humulin N
Dosage Form
-
Usage Information
INSTRUCTIONS FOR INSULIN VIAL USENEVER SHARE NEEDLES AND SYRINGES.Correct Syringe TypeDoses of insulin are measured in units. U–100 insulin contains 100 units/mL (1 mL=1 cc). With Humulin N, it is important to use a syringe that is marked for U–100 insulin preparations. Failure to use the proper syringe can lead to a mistake in dosage, causing serious problems for you, such as a blood glucose level that is too low or too high.Syringe UseTo help avoid contamination and possible infection, follow these instructions exactly.Disposable syringes and needles should be used only once and then discarded by placing the used needle in a puncture-resistant disposable container. Properly dispose of the puncture-resistant container as directed by your Health Care Professional.Preparing the DoseWash your hands.Carefully shake or rotate the bottle of insulin several times to completely mix the insulin.Inspect the insulin. Humulin N suspension should look uniformly cloudy or milky. Do not use Humulin N if you notice anything unusual in its appearance.If using a new Humulin N bottle, flip off the plastic protective cap, but do not remove the stopper. Wipe the top of the bottle with an alcohol swab.If you are mixing insulins, refer to the “Mixing Humulin N and Regular Human Insulin” section below.Draw an amount of air into the syringe that is equal to the Humulin N dose. Put the needle through rubber top of the Humulin N bottle and inject the air into the bottle.Turn the Humulin N bottle and syringe upside down. Hold the bottle and syringe firmly in one hand and shake gently.Making sure the tip of the needle is in the Humulin N suspension, withdraw the correct dose of Humulin N into the syringe.Before removing the needle from the Humulin N bottle, check the syringe for air bubbles. If bubbles are present, hold the syringe straight up and tap its side until the bubbles float to the top. Push the bubbles out with the plunger and then withdraw the correct dose.Remove the needle from the bottle and lay the syringe down so that the needle does not touch anything.If you do not need to mix your Humulin N with Regular human insulin, go to the “Injection Instructions” section below and follow the directions.Mixing Humulin N and Regular Human Insulin (Humulin R)Humulin N should be mixed with Humulin R only on the advice of your doctor.Draw an amount of air into the syringe that is equal to the amount of Humulin N you are taking. Insert the needle into the Humulin N bottle and inject the air. Withdraw the needle.Draw an amount of air into the syringe that is equal to the amount of Humulin R you are taking. Insert the needle into the Humulin R bottle and inject the air, but do not withdraw the needle.Turn the Humulin R bottle and syringe upside down.Making sure the tip of the needle is in the Humulin R solution, withdraw the correct dose of Humulin R into the syringe.Before removing the needle from the Humulin R bottle, check the syringe for air bubbles. If bubbles are present, hold the syringe straight up and tap its side until the bubbles float to the top. Push the bubbles out with the plunger and then withdraw the correct dose.Remove the syringe with the needle from the Humulin R bottle and insert it into the Humulin N bottle. Turn the Humulin N bottle and syringe upside down. Hold the bottle and syringe firmly in one hand and shake gently. Making sure the tip of the needle is in the Humulin N, withdraw the correct dose of Humulin N.Remove the needle from the bottle and lay the syringe down so that the needle does not touch anything.Follow the directions under “Injection Instructions” section below.Follow your doctor’s instructions on whether to mix your insulins ahead of time or just before giving your injection. It is important to be consistent in your method.Syringes from different manufacturers may vary in the amount of space between the bottom line and the needle. Because of this, do not change:the sequence of mixing, orthe model and brand of syringe or needle that your doctor has prescribed.Injection InstructionsTo avoid tissue damage, choose a site for each injection that is at least 1/2 inch from the previous injection site. The usual sites of injection are abdomen, thighs, and arms.Cleanse the skin with alcohol where the injection is to be made.With one hand, stabilize the skin by spreading it or pinching up a large area.Insert the needle as instructed by your doctor.Push the plunger in as far as it will go.Pull the needle out and apply gentle pressure over the injection site for several seconds. Do not rub the area.Place the used needle in a puncture-resistant disposable container and properly dispose of the puncture-resistant container as directed by your Health Care Professional.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA018781
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-24-1994
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 54868-1429-1 identifies a specific commercial package of 1 vial in 1 carton / 10 ml in 1 vial of Humulin N, 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 October 24, 1994. 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: 54868142901. 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)
54868-1429-1
11-Digit CMS (5-4-2)
54868-1429-01

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