Ledipasvir And Sofosbuvir Tablet, Film Coated
NDC Package 72626-2601-1

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

Package Information

Ledipasvir And Sofosbuvir tablets is if ledipasvir and sofosbuvir tablets are administered with ribavirin, the contraindications to ribavirin also apply to this combination regimen. This formulation utilizes a tablet, film coated delivery system. Marketed by Asegua Therapeutics Llc, this product is identified by NDC 72626-2601 and is authorized under FDA application NDA205834.

Identification & Billing

NDC Package Code
72626-2601-1
Package Description
2 BLISTER PACK in 1 CARTON / 14 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
72626-2601
11-Digit Billing Format
72626260101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
2 EA
RxNorm Crosswalk
RxCUI: 1591943 - ledipasvir 90 MG / sofosbuvir 400 MG Oral Tablet

Clinical Specifications

Proprietary Name
Ledipasvir And Sofosbuvir
Non-Proprietary Name
Ledipasvir And Sofosbuvir
Substance Name
Ledipasvir; Sofosbuvir
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
If ledipasvir and sofosbuvir tablets are administered with ribavirin, the contraindications to ribavirin also apply to this combination regimen. Refer to the ribavirin prescribing information for a list of contraindications for ribavirin [see Dosage and Administration (2.2)].

Regulatory & Marketing

Labeler Name
Asegua Therapeutics Llc
Product Type
Human Prescription Drug
FDA Application #
NDA205834
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
01-01-2019
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 72626-2601-1 identifies a specific commercial package of 2 blister pack in 1 carton / 14 tablet, film coated in 1 blister pack of Ledipasvir And Sofosbuvir, a human prescription drug labeled by Asegua Therapeutics Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 2 billable units per package. This tablet, film coated is formulated for oral use and contains ledipasvir; sofosbuvir 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 Asegua Therapeutics Llc on January 01, 2019. The current certification is valid through December 31, 2026.

How is this Asegua Therapeutics Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72626260101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 2 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 (5-4-1)
72626-2601-1
11-Digit CMS (5-4-2)
72626-2601-01

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