NDC Package 45802-169-72 Alogliptin And Metformin Hydrochloride

Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

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:
45802-169-72
Package Description:
60 TABLET, FILM COATED in 1 BOTTLE
Product Code:
Proprietary Name:
Alogliptin And Metformin Hydrochloride
Non-Proprietary Name:
Alogliptin And Metformin Hydrochloride
Substance Name:
Alogliptin Benzoate; Metformin Hydrochloride
Usage Information:
Alogliptin and metformin HCl tablets are contraindicated in patients with:Severe renal impairment (eGFR below 30 mL/min/1.73 m2) [see Warnings and Precautions (5.1)].Acute or chronic metabolic acidosis, including diabetic ketoacidosis. Diabetic ketoacidosis should be treated with insulin.History of a serious hypersensitivity reaction to alogliptin or metformin, components of alogliptin and metformin HCl tablets, such as anaphylaxis, angioedema or severe cutaneous adverse reactions.
11-Digit NDC Billing Format:
45802016972
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
60 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1368385 - alogliptin 12.5 MG / metFORMIN HCl 1000 MG Oral Tablet
  • RxCUI: 1368385 - alogliptin 12.5 MG / metformin hydrochloride 1000 MG Oral Tablet
  • RxCUI: 1368385 - alogliptin 12.5 MG (as alogliptin benzoate 17 MG) / metformin hydrochloride 1000 MG Oral Tablet
  • RxCUI: 1368392 - alogliptin 12.5 MG / metFORMIN HCl 500 MG Oral Tablet
  • RxCUI: 1368392 - alogliptin 12.5 MG / metformin hydrochloride 500 MG Oral Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Padagis Israel Pharmaceuticals Ltd
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Sample Package:
    No
    FDA Application Number:
    NDA203414
    Marketing Category:
    NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
    Start Marketing Date:
    04-08-2016
    Listing Expiration Date:
    12-31-2025
    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 45802-169-72?

    The NDC Packaged Code 45802-169-72 is assigned to a package of 60 tablet, film coated in 1 bottle of Alogliptin And Metformin Hydrochloride, a human prescription drug labeled by Padagis Israel Pharmaceuticals Ltd. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 45802-169 included in the NDC Directory?

    Yes, Alogliptin And Metformin Hydrochloride with product code 45802-169 is active and included in the NDC Directory. The product was first marketed by Padagis Israel Pharmaceuticals Ltd on April 08, 2016 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 45802-169-72?

    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 60.

    What is the 11-digit format for NDC 45802-169-72?

    The 11-digit format is 45802016972. 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
    5-3-245802-169-725-4-245802-0169-72