Humulin N
NDC 54868-1429

View NDC Profile UNII Mappings and RxNorm Concepts.

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Humulin N is a NDA-approved product labeled by Physicians Total Care, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a product. This product entry covers the primary NDC 54868-1429 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
54868-1429
Proprietary Name:
Humulin N
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Code:
54868
FDA Application Number: [6]
NDA018781
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
10-24-1994
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I

Code Structure Chart

Product Details

What is NDC 54868-1429?

The NDC code 54868-1429 is assigned by the FDA to the product Humulin N. This pharmaceutical product is labeled by Physicians Total Care, Inc. and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 54868-1429-1. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • 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

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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".