Novolin Injection, Solution
NDC Package 0169-3003-15

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

Novolin (human insulin) injection is insulin regular is used with a proper diet and exercise program to control high blood sugar in people with diabetes. This formulation utilizes a injection, solution delivery system. Marketed by Novo Nordisk, this product is identified by NDC 0169-3003 and is authorized under FDA application BLA019938.

Identification & Billing

NDC Package Code
0169-3003-15
Package Description
5 SYRINGE, PLASTIC in 1 CARTON / 3 mL in 1 SYRINGE, PLASTIC (0169-3003-01)
Product Code
0169-3003
11-Digit Billing Format
00169300315
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 2206090 - insulin regular, human 100 UNT/1 mL in 3 mL Pen Injector
  • RxCUI: 2206090 - 3 ML insulin, regular, human 100 UNT/ML Pen Injector
  • RxCUI: 2206090 - insulin regular, human 100 UNT/1 ML per 3 ML Pen Injector
  • RxCUI: 2206092 - NovoLIN R 100 UNT/mL in 3 mL Pen Injector
  • RxCUI: 2206092 - 3 ML insulin, regular, human 100 UNT/ML Pen Injector [Novolin R]

Clinical Specifications

Proprietary Name
Novolin R
Non-Proprietary Name
Human Insulin
Substance Name
Insulin Human
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
INSULIN HUMAN 100 [iU]/mL
Pharmacologic Class
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
Novo Nordisk
Product Type
Human Otc Drug
FDA Application #
BLA019938
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
09-06-2019
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0169-3003). Click a package code to view its specific billing and regulatory data.

0169-3003-25
5 SYRINGE, PLASTIC in 1 CARTON / 3 mL in 1 SYRINGE, PLASTIC (0169-3003-12)

* 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 0169-3003-15 identifies a specific commercial package of 5 syringe, plastic in 1 carton / 3 ml in 1 syringe, plastic (0169-3003-01) of Novolin R, a human over the counter drug labeled by Novo Nordisk. This injection, solution is formulated for subcutaneous use and contains insulin human 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 on September 06, 2019. The current certification is valid through December 31, 2026.

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 Novo Nordisk product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00169300315. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
0169-3003-15
11-Digit CMS (5-4-2)
00169-3003-15

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