Afrezza Kit
NDC Package 47918-902-18

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Afrezza (insulin human) kits is inhaled insulin powder is used with a proper diet and exercise program to control high blood sugar in people with diabetes. This formulation utilizes a kit delivery system. Marketed by Mannkind Corporation, this product is identified by NDC 47918-902 and is authorized under FDA application BLA022472.

Identification & Billing

NDC Package 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
Product Code
47918-902
11-Digit Billing Format
47918090218
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Afrezza
Non-Proprietary Name
Insulin Human
Dosage Form
Kit - A packaged collection of related material.
Administration Route
Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Usage Information
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).

Regulatory & Marketing

Labeler Name
Mannkind Corporation
Product Type
Human Prescription Drug
FDA Application #
BLA022472
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
01-10-2017
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage
  • 47918 - Mannkind Corporation
    • 47918-902 - Afrezza
      • 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

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 47918-902-18 identifies a specific commercial package of 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 of Afrezza, a human prescription drug labeled by Mannkind Corporation. This kit is formulated for respiratory (inhalation) use and contains as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Mannkind Corporation on January 10, 2017. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

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).

How is this Mannkind Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 47918090218. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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 (5-3-2)
47918-902-18
11-Digit CMS (5-4-2)
47918-0902-18

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