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  5. NDC Package Code: 49502-394-75 Insulin Glargine

NDC Package 49502-394-75 Insulin Glargine

Insulin Glargine-yfgn Injection, Solution Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
49502-394-75
Package Description:
5 SYRINGE in 1 CARTON / 3 mL in 1 SYRINGE (49502-394-71)
Product Code:
49502-394
Proprietary Name:
Insulin Glargine
Non-Proprietary Name:
Insulin Glargine-yfgn
Substance Name:
Insulin Glargine
Usage Information:
Insulin glargine injection is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.Limitations of UseInsulin glargine injection is not recommended for the treatment of diabetic ketoacidosis.
11-Digit NDC Billing Format:
49502039475
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 2563971 - insulin glargine-yfgn 300 UNT in 3 ML Pen Injector
  • RxCUI: 2563971 - 3 ML insulin glargine-yfgn 100 UNT/ML Pen Injector
  • RxCUI: 2563971 - insulin glargine-yfgn 100 UNT/ML per 3 ML Pen Injector
  • RxCUI: 2563971 - insulin glargine-yfgn 300 UNT per 3 ML Pen Injector
  • RxCUI: 2563976 - insulin glargine-yfgn 100 UNT/ML Injectable Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Mylan Specialty L.p.
    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(s):
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Active Ingredient(s):
  • INSULIN GLARGINE 100 [iU]/mL
    • Pharmacologic Class(es):
  • Insulin Analog - [EPC] (Established Pharmacologic Class)
  • Insulin - [CS]
    • Sample Package:
    No
    FDA Application Number:
    BLA761201
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    11-16-2021
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 49502-394-75?

    The NDC Packaged Code 49502-394-75 is assigned to a package of 5 syringe in 1 carton / 3 ml in 1 syringe (49502-394-71) of Insulin Glargine, a human prescription drug labeled by Mylan Specialty L.p.. The product's dosage form is injection, solution and is administered via subcutaneous form.

    Is NDC 49502-394 included in the NDC Directory?

    Yes, Insulin Glargine with product code 49502-394 is active and included in the NDC Directory. The product was first marketed by Mylan Specialty L.p. on November 16, 2021 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 49502-394-75?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 49502-394-75?

    The 11-digit format is 49502039475. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-249502-394-755-4-249502-0394-75