Rybelsus Tablet
NDC Package 0169-4307-13

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

Package Information

Rybelsus (oral semaglutide) tablets is semaglutide is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. This formulation utilizes a tablet delivery system. Marketed by Novo Nordisk Pharmaceutical Industries, Lp, this product is identified by NDC 0169-4307 and is authorized under FDA application NDA213051.

Identification & Billing

NDC Package Code
0169-4307-13
Package Description
3 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK (0169-4307-01)
Product Code
0169-4307
11-Digit Billing Format
00169430713
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
3 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Rybelsus
Non-Proprietary Name
Oral Semaglutide
Substance Name
Semaglutide
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SEMAGLUTIDE 7 mg/1
Pharmacologic Class
Usage Information
Semaglutide is used with a proper diet and exercise program to control high blood sugar in people with type 2 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. Semaglutide is similar to a natural hormone in your body (incretin). It works by causing insulin release in response to high blood sugar (such as after a meal) and decreasing the amount of sugar your liver makes.

Regulatory & Marketing

Labeler Name
Novo Nordisk Pharmaceutical Industries, Lp
Product Type
Human Prescription Drug
FDA Application #
NDA213051
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-20-2019
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0169-4307). Click a package code to view its specific billing and regulatory data.

0169-4307-30
30 TABLET in 1 BOTTLE, GLASS

* 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 0169-4307-13 identifies a specific commercial package of 3 blister pack in 1 carton / 10 tablet in 1 blister pack (0169-4307-01) of Rybelsus, a human prescription drug labeled by Novo Nordisk Pharmaceutical Industries, Lp. This tablet is formulated for oral use and contains semaglutide 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 Novo Nordisk Pharmaceutical Industries, Lp on September 20, 2019. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Semaglutide is used with a proper diet and exercise program to control high blood sugar in people with type 2 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. Semaglutide is similar to a natural hormone in your body (incretin). It works by causing insulin release in response to high blood sugar (such as after a meal) and decreasing the amount of sugar your liver makes.

How is this Novo Nordisk Pharmaceutical Industries, Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00169430713. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 3 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 (4-4-2)
0169-4307-13
11-Digit CMS (5-4-2)
00169-4307-13

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