Novolin
NDC Package 54868-3474-0

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 read the instructions for use that come with your Novolin 70/30 product. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-3474 and is authorized under FDA application NDA019991.

Identification & Billing

NDC Package Code
54868-3474-0
Package Description
1 VIAL in 1 CARTON / 10 mL in 1 VIAL
Product Code
54868-3474
11-Digit Billing Format
54868347400
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 213442 - NovoLIN 70/30 Injectable Suspension
  • RxCUI: 213442 - insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Injectable Suspension [Novolin]
  • RxCUI: 213442 - Novolin 70/30 Injectable Suspension
  • RxCUI: 213442 - Relion Novolin 70/30 Injectable Suspension
  • RxCUI: 311048 - insulin, human isophane / insulin regular 70/30 Injectable Suspension

Clinical Specifications

Proprietary Name
Novolin 70/30
Dosage Form
-
Usage Information
Read the instructions for use that come with your Novolin 70/30 product. Talk to your healthcare provider if you have any questions. Your healthcare provider should show you how to inject Novolin 70/30 before you start taking it. Follow your healthcare provider’s instructions to make changes to your insulin dose.Take Novolin 70/30 exactly as prescribed.Novolin 70/30 is an intermediate-acting insulin. The effects of Novolin 70/30 start working ½ hour after injection. The greatest blood sugar lowering effect is between 2 and 12 hours after the injection. This blood sugar lowering may last up to 24 hours.While using Novolin 70/30, any change of insulin should be made cautiously and only under medical supervision. Doses of oral anti-diabetic medicines may also need to change, if your insulin is changed. Do not mix Novolin 70/30 with any insulins. Inject Novolin 70/30 into the skin of your stomach area, upper arms, buttocks or upper legs. Novolin 70/30 may affect your blood sugar levels sooner if you inject it into the skin of your stomach area. Never inject Novolin 70/30 into a vein or into a muscle.Change (rotate) your injection site within the chosen area (for example, stomach or upper arm) with each dose. Do not inject into the same spot for each injection.If you take too much Novolin  70/30, your blood sugar may fall low (hypoglycemia). You can treat mild low blood sugar (hypoglycemia) by drinking or eating something sugary right away (fruit juice, sugar candies, or glucose tablets). It is important to treat low blood sugar (hypoglycemia) right away because it could get worse and you could pass out (become unconscious). If you pass out, you will need help from another person or emergency medical services right away, and will need treatment with a glucagon injection or treatment at a hospital. See “What are the possible side effects of Novolin  70/30?” for more information on low blood sugar (hypoglycemia). If you forget to take your dose of Novolin  70/30, your blood sugar may go too high (hyperglycemia). If  high blood sugar (hyperglycemia) is not treated it can lead to diabetic ketoacidosis, which can lead to serious problems, like loss of consciousness (passing out), coma or even death. Follow your healthcare provider’s instructions for treating high blood sugar (hyperglycemia), and talk to your healthcare provider if high blood sugar is a problem for you. Severe or continuing high blood sugar (hyperglycemia) requires prompt evaluation and treatment by your healthcare provider. Know your symptoms of high blood sugar (hyperglycemia) and diabetic ketoacidosis which may include:increased thirstfrequent urination and dehydrationconfusion or drowsinessloss of appetitefruity smell on breathhigh amounts of sugar and ketones in your urinenausea, vomiting (throwing up) or stomach paina hard time breathingCheck your blood sugar levels. Ask your healthcare provider how often you should check your blood sugar levels for hypoglycemia (too low blood sugar) and hyperglycemia (too high blood sugar).Your insulin dosage may need to change because of:illnessstressother medicines you takechange in dietchange in physical activity or exercisesurgerySee the end of this patient information for instructions about preparing and giving the injection.What should I avoid while using Novolin 70/30?Alcohol. Alcohol, including beer and wine, may affect your blood sugar when you take Novolin 70/30. Driving and operating machinery. You may have difficulty concentrating or reacting if you have low blood sugar (hypoglycemia). Be careful when you drive a car or operate machinery. Ask your healthcare provider if it is alright to drive if you often have: low blood sugar decreased or no warning signs of low blood sugar

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA019991
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-11-1995
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 54868-3474-0 identifies a specific commercial package of 1 vial in 1 carton / 10 ml in 1 vial of Novolin 70/30, labeled by Physicians Total Care, Inc.. 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 Physicians Total Care, Inc. on January 11, 1995. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868347400. 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 (5-4-1)
54868-3474-0
11-Digit CMS (5-4-2)
54868-3474-00

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