Inpefa Tablet
NDC Package 70183-221-07

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

Package Information

Inpefa (sotagliflozin) tablets is iNPEFA is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with: heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. This formulation utilizes a tablet delivery system. Marketed by Lexicon Pharmaceuticals, Inc., this product is identified by NDC 70183-221 and is authorized under FDA application NDA216203.

Identification & Billing

NDC Package Code
70183-221-07
Package Description
1 BLISTER PACK in 1 CARTON / 7 TABLET in 1 BLISTER PACK
Product Code
70183-221
11-Digit Billing Format
70183022107
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Inpefa
Non-Proprietary Name
Sotagliflozin
Substance Name
Sotagliflozin
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SOTAGLIFLOZIN 200 mg/1
Pharmacologic Class
Usage Information
INPEFA is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with: heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors

Regulatory & Marketing

Labeler Name
Lexicon Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA216203
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-26-2023
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
Yes

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (70183-221). Click a package code to view its specific billing and regulatory data.

70183-221-30
30 TABLET in 1 BOTTLE
70183-221-31
1 BLISTER PACK in 1 CARTON / 3 BLISTER PACK in 1 BLISTER PACK / 10 TABLET in 1 BLISTER PACK

* 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 70183-221-07 identifies a specific commercial package of 1 blister pack in 1 carton / 7 tablet in 1 blister pack of Inpefa, a human prescription drug labeled by Lexicon Pharmaceuticals, Inc.. This tablet is formulated for oral use and contains sotagliflozin 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 Lexicon Pharmaceuticals, Inc. on May 26, 2023. The current certification is valid through December 31, 2027.

How is this Lexicon Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70183022107. 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)
70183-221-07
11-Digit CMS (5-4-2)
70183-0221-07

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