NDC 47918-891 Afrezza
Insulin Human Powder, Metered Respiratory (inhalation) - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 47918 - Mannkind Corporation
- 47918-891 - Afrezza
Product Packages
NDC Code 47918-891-90
Package Description: 3 POUCH in 1 CARTON / 2 BLISTER PACK in 1 POUCH / 15 CARTRIDGE in 1 BLISTER PACK / 1 POWDER, METERED in 1 CARTRIDGE
Product Details
What is NDC 47918-891?
What are the uses for Afrezza?
What are Afrezza Active Ingredients?
Which are Afrezza UNII Codes?
The UNII codes for the active ingredients in this product are:
- INSULIN HUMAN (UNII: 1Y17CTI5SR)
- INSULIN HUMAN (UNII: 1Y17CTI5SR) (Active Moiety)
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:
- FUMARYL DIKETOPIPERAZINE (UNII: XB09609XSL)
- POLYSORBATE 80 (UNII: 6OZP39ZG8H)
What is the NDC to RxNorm Crosswalk for Afrezza?
- RxCUI: 1543202 - regular insulin, human 4 UNT Inhalation Powder Cartridge
- RxCUI: 1543202 - insulin, regular, human 4 UNT Inhalation Powder
- RxCUI: 1543207 - afrezza 4 UNT Inhalation Powder
- RxCUI: 1543207 - insulin, regular, human 4 UNT Inhalation Powder [Afrezza]
- RxCUI: 1543207 - Afrezza 4 UNT Inhalation Powder
Which are the Pharmacologic Classes for Afrezza?
* 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.
[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.
[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
[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".