Alogliptin And Pioglitazone Tablet, Film Coated
NDC Package 45802-402-65

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

Package Information

Alogliptin And Pioglitazone (alogliptin benzoate and pioglitazone hydrochloride) tablets is history of a serious hypersensitivity reaction to alogliptin or pioglitazone, components of alogliptin and pioglitazone tablets, such as anaphylaxis, angioedema or severe cutaneous adverse reactions.Do not initiate in patients with NYHA Class III or IV heart failure [see Boxed Warning]. This formulation utilizes a tablet, film coated delivery system. Marketed by Padagis Israel Pharmaceuticals Ltd, this product is identified by NDC 45802-402 and is authorized under FDA application NDA022426.

Identification & Billing

NDC Package Code
45802-402-65
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
45802-402
11-Digit Billing Format
45802040265
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
  • RxCUI: 1368410 - alogliptin 12.5 MG / pioglitazone 30 MG Oral Tablet
  • RxCUI: 1368410 - alogliptin 12.5 MG (as alogliptin benzoate 17 MG) / pioglitazone 30 MG (as pioglitazone hydrochloride 33.06 MG) Oral Tablet
  • RxCUI: 1368424 - alogliptin 25 MG / pioglitazone 15 MG Oral Tablet
  • RxCUI: 1368424 - alogliptin 25 MG (as alogliptin benzoate 34 MG) / pioglitazone 15 MG (as pioglitazone hydrochloride 16.53 MG) Oral Tablet
  • RxCUI: 1368431 - alogliptin 25 MG / pioglitazone 30 MG Oral Tablet

Clinical Specifications

Proprietary Name
Alogliptin And Pioglitazone
Non-Proprietary Name
Alogliptin Benzoate And Pioglitazone Hydrochloride
Substance Name
Alogliptin Benzoate; Pioglitazone 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
History of a serious hypersensitivity reaction to alogliptin or pioglitazone, components of alogliptin and pioglitazone tablets, such as anaphylaxis, angioedema or severe cutaneous adverse reactions.Do not initiate in patients with NYHA Class III or IV heart failure [see Boxed Warning].

Regulatory & Marketing

Labeler Name
Padagis Israel Pharmaceuticals Ltd
Product Type
Human Prescription Drug
FDA Application #
NDA022426
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 45802-402-65 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Alogliptin And Pioglitazone, a human prescription drug labeled by Padagis Israel Pharmaceuticals Ltd. This tablet, film coated is formulated for oral use and contains alogliptin benzoate; pioglitazone 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: 45802040265. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
45802-402-65
11-Digit CMS (5-4-2)
45802-0402-65

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