Hyftor Gel
NDC Package 73683-101-10

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

Package Information

Hyftor (sirolimus) gel is sirolimus is used with other medications to prevent rejection of a kidney transplant. This formulation utilizes a gel delivery system. Marketed by Nobelpharma America, Llc, this product is identified by NDC 73683-101 and is authorized under FDA application NDA213478.

Identification & Billing

NDC Package Code
73683-101-10
Package Description
1 TUBE in 1 CARTON / 10 g in 1 TUBE
Product Code
73683-101
11-Digit Billing Format
73683010110
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
10 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Hyftor
Non-Proprietary Name
Sirolimus
Substance Name
Sirolimus
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
SIROLIMUS 2 mg/g
Pharmacologic Class
Usage Information
Sirolimus is used with other medications to prevent rejection of a kidney transplant. This medication belongs to a class of drugs known as immunosuppressants. It works by weakening your body's defense system (immune system) to help your body accept the new organ as if it were your own. Sirolimus may also be used to treat a certain lung disease (lymphangioleiomyomatosis-LAM).

Regulatory & Marketing

Labeler Name
Nobelpharma America, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA213478
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-23-2022
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 73683-101-10 identifies a specific commercial package of 1 tube in 1 carton / 10 g in 1 tube of Hyftor, a human prescription drug labeled by Nobelpharma America, Llc. This product is billed per "GM" gram and contains an estimated amount of 10 billable units per package. This gel is formulated for topical use and contains sirolimus 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 Nobelpharma America, Llc on March 23, 2022. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Sirolimus is used with other medications to prevent rejection of a kidney transplant. This medication belongs to a class of drugs known as immunosuppressants. It works by weakening your body's defense system (immune system) to help your body accept the new organ as if it were your own. Sirolimus may also be used to treat a certain lung disease (lymphangioleiomyomatosis-LAM).

How is this Nobelpharma America, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 73683010110. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 10 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)
73683-101-10
11-Digit CMS (5-4-2)
73683-0101-10

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