Alogliptin And Metformin Hydrochloride Tablet, Film Coated
NDC Package 45802-211-72

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Alogliptin And Metformin Hydrochloride tablets is 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. This formulation utilizes a tablet, film coated delivery system. Marketed by Padagis Israel Pharmaceuticals Ltd, this product is identified by NDC 45802-211 and is authorized under FDA application NDA203414.

Identification & Billing

NDC Package Code
45802-211-72
Package Description
60 TABLET, FILM COATED in 1 BOTTLE
Product Code
45802-211
11-Digit Billing Format
45802021172
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
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

Clinical Specifications

Proprietary Name
Alogliptin And Metformin Hydrochloride
Non-Proprietary Name
Alogliptin And Metformin Hydrochloride
Substance Name
Alogliptin Benzoate; Metformin Hydrochloride
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Padagis Israel Pharmaceuticals Ltd
Product Type
Human Prescription Drug
FDA Application #
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
12-31-2026
Exclude Flag
N
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 45802-211-72 identifies a specific commercial package of 60 tablet, film coated in 1 bottle of Alogliptin And Metformin Hydrochloride, a human prescription drug labeled by Padagis Israel Pharmaceuticals Ltd. This tablet, film coated is formulated for oral use and contains alogliptin benzoate; metformin hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Padagis Israel Pharmaceuticals Ltd on April 08, 2016. The current certification is valid through December 31, 2026.

How is this Padagis Israel Pharmaceuticals Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45802021172. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 total billable units per package. 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 (5-3-2)
45802-211-72
11-Digit CMS (5-4-2)
45802-0211-72

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