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  5. NDC Package Code: 71610-578-70 Metformin Hydrochloride

NDC Package 71610-578-70 Metformin Hydrochloride

Tablet, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
71610-578-70
Package Description:
120 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code:
71610-578
Proprietary Name:
Metformin Hydrochloride
Non-Proprietary Name:
Metformin Hydrochloride
Substance Name:
Metformin Hydrochloride
Usage Information:
Metformin hydrochloride tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Metformin hydrochloride extended-release tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
11-Digit NDC Billing Format:
71610057870
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
120 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 860975 - metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet
  • RxCUI: 860975 - 24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet
  • RxCUI: 860975 - metformin HCl 500 MG 24 HR Extended Release Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Aphena Pharma Solutions - Tennessee, Llc
    Dosage Form:
    Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • METFORMIN HYDROCHLORIDE 500 mg/1
    • Pharmacologic Class(es):
  • Biguanide - [EPC] (Established Pharmacologic Class)
  • Biguanides - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA206145
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-27-2018
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    71610-578-6090 TABLET, EXTENDED RELEASE in 1 BOTTLE
    71610-578-80180 TABLET, EXTENDED RELEASE in 1 BOTTLE
    71610-578-94360 TABLET, EXTENDED RELEASE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 71610-578-70?

    The NDC Packaged Code 71610-578-70 is assigned to a package of 120 tablet, extended release in 1 bottle of Metformin Hydrochloride, a human prescription drug labeled by Aphena Pharma Solutions - Tennessee, Llc. The product's dosage form is tablet, extended release and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 120 billable units per package.

    Is NDC 71610-578 included in the NDC Directory?

    Yes, Metformin Hydrochloride with product code 71610-578 is active and included in the NDC Directory. The product was first marketed by Aphena Pharma Solutions - Tennessee, Llc on October 27, 2018 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 71610-578-70?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 120.

    What is the 11-digit format for NDC 71610-578-70?

    The 11-digit format is 71610057870. 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
    5-3-271610-578-705-4-271610-0578-70