Novolin
NDC Package 64725-1833-1

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Novolin is insulin regular is used with a proper diet and exercise program to control high blood sugar in people with diabetes. Marketed by Tya Pharmaceuticals, this product is identified by NDC 64725-1833 and is authorized under FDA application NDA019938.

Identification & Billing

NDC Package Code
64725-1833-1
Package Description
10 mL in 1 VIAL
Product Code
64725-1833
11-Digit Billing Format
64725183301
RxNorm Crosswalk
  • RxCUI: 311033 - NovoLIN R 100 UNT/ML Injectable Solution
  • RxCUI: 311033 - insulin, regular, human 100 UNT/ML Injectable Solution [Novolin R]
  • RxCUI: 311033 - Novolin R 100 UNT/ML Injectable Solution
  • RxCUI: 311034 - regular insulin, human 100 UNT/ML Injectable Solution
  • RxCUI: 311034 - insulin, regular, human 100 UNT/ML Injectable Solution

Clinical Specifications

Proprietary Name
Novolin R
Dosage Form
-
Usage Information
Insulin regular 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 medication 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
Tya Pharmaceuticals
FDA Application #
NDA019938
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-25-1991
Listing Expiration
12-31-2017
Exclude Flag
I
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 64725-1833-1 identifies a specific commercial package of 10 ml in 1 vial of Novolin R, labeled by Tya Pharmaceuticals. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Tya Pharmaceuticals on June 25, 1991. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

Insulin regular 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 medication 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 Tya Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64725183301. 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 (5-4-1)
64725-1833-1
11-Digit CMS (5-4-2)
64725-1833-01

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