Afrezza Kit
NDC Package 47918-902-18

11-digit billing NDC: 47918090218 · Billing unit: EA · 1 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Afrezza (insulin human) kits is aFREZZA ® is indicated to improve glycemic control in adult and pediatric patients 6 years of age and older with diabetes mellitus. 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.
Units Per Package
1 EA
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
AFREZZA ® is indicated to improve glycemic control in adult and pediatric patients 6 years of age and older with diabetes mellitus.

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.

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.. There are 1 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 (5-3-2)
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.