NDC 47918-902 Afrezza

Insulin Human Kit Respiratory (inhalation) - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
47918-902
Proprietary Name:
Afrezza
Non-Proprietary Name: [1]
Insulin Human
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Administration Route(s): [4]
  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
  • Labeler Name: [5]
    Mannkind Corporation
    Labeler Code:
    47918
    FDA Application Number: [6]
    BLA022472
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    01-10-2017
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 47918-902-18

    Package Description: 1 KIT in 1 CARTON * 2 POUCH in 1 PACKAGE, COMBINATION / 2 BLISTER PACK in 1 POUCH / 15 CARTRIDGE in 1 BLISTER PACK / 1 POWDER, METERED in 1 CARTRIDGE * 2 POUCH in 1 PACKAGE, COMBINATION / 2 BLISTER PACK in 1 POUCH / 15 CARTRIDGE in 1 BLISTER PACK / 1 POWDER, METERED in 1 CARTRIDGE * 2 POUCH in 1 PACKAGE, COMBINATION / 2 BLISTER PACK in 1 POUCH / 15 CARTRIDGE in 1 BLISTER PACK / 1 POWDER, METERED in 1 CARTRIDGE

    Price per Unit: $7.54949 per EA

    Product Details

    What is NDC 47918-902?

    The NDC code 47918-902 is assigned by the FDA to the product Afrezza which is a human prescription drug product labeled by Mannkind Corporation. The generic name of Afrezza is insulin human. The product's dosage form is kit and is administered via respiratory (inhalation) form. The product is distributed in a single package with assigned NDC code 47918-902-18 1 kit in 1 carton * 2 pouch in 1 package, combination / 2 blister pack in 1 pouch / 15 cartridge in 1 blister pack / 1 powder, metered in 1 cartridge * 2 pouch in 1 package, combination / 2 blister pack in 1 pouch / 15 cartridge in 1 blister pack / 1 powder, metered in 1 cartridge * 2 pouch in 1 package, combination / 2 blister pack in 1 pouch / 15 cartridge in 1 blister pack / 1 powder, metered in 1 cartridge. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Afrezza?

    Inhaled insulin powder is used with a proper diet and exercise program to control high blood sugar in people with diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. This man-made insulin product is the same as human insulin. It replaces the insulin that your body would normally make. It is a short-acting insulin. It works by helping blood sugar (glucose) get into cells so your body can use it for energy. This product is absorbed into the blood through your lungs. It starts working faster and lasts for a shorter time than regular insulin injected under the skin. It is usually used in combination with a medium- or long-acting insulin product. This medication may also be used alone or with other oral diabetes drugs (such as metformin).

    Which are Afrezza UNII Codes?

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

    Which are Afrezza Inactive Ingredients 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 Afrezza?

    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:

    * Please review the disclaimer below.

    Patient Education

    Insulin Human Inhalation


    Insulin inhalation is used in combination with a long-acting insulin to treat type 1 diabetes (condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood). It is also used in combination with other medications to treat people with type 2 diabetes (condition in which the body does not use insulin normally and, therefore, cannot control the amount of sugar in the blood) who need insulin to control their diabetes. Insulin inhalation is not used for the treatment diabetic ketoacidosis (a serious condition that may develop if high blood sugar is not treated). Insulin inhalation is a short-acting, man-made version of human insulin. Insulin inhalation works by replacing the insulin that is normally produced by the body and by helping to move sugar from the blood into other body tissues where it is used for energy. It also stops the liver from producing more sugar. Over time, people who have diabetes and high blood sugar can develop serious or life-threatening complications, including heart disease, stroke, kidney problems, nerve damage, and eye problems. Using medication(s), making lifestyle changes (e.g., diet, exercise, quitting smoking), and regularly checking your blood sugar may help to manage your diabetes and improve your health. This therapy may also decrease your chances of having a heart attack, stroke, or other diabetes-related complications such as kidney failure, nerve damage (numb, cold legs or feet; decreased sexual ability in men and women), eye problems, including changes or loss of vision, or gum disease. Your doctor and other healthcare providers will talk to you about the best way to manage your diabetes.
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    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] 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.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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.

    [12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".