Novolin
NDC 54868-3474

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 54868-3474?
  4. Novolin 70/30 Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

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

Novolin is a NDA-approved product labeled by Physicians Total Care, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a product. This product entry covers the primary NDC 54868-3474 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
54868-3474
Proprietary Name:
Novolin 70/30
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Physicians Total Care, Inc.
Labeler Code:
54868
Product Label ID:
8c7038f4-60d4-4604-814d-74921cdc1ad8
FDA Application Number: [6]
NDA019991
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
01-11-1995
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I

Code Structure Chart

Product Details

What is NDC 54868-3474?

The NDC code 54868-3474 is assigned by the FDA to the product Novolin 70/30. This pharmaceutical product is labeled by Physicians Total Care, Inc. and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 54868-3474-0. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • 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

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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".