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  5. NDC Package Code: 72626-2601-1 Ledipasvir And Sofosbuvir

NDC Package 72626-2601-1 Ledipasvir And Sofosbuvir

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

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

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:
72626-2601-1
Package Description:
2 BLISTER PACK in 1 CARTON / 14 TABLET, FILM COATED in 1 BLISTER PACK
Product Code:
72626-2601
Proprietary Name:
Ledipasvir And Sofosbuvir
Non-Proprietary Name:
Ledipasvir And Sofosbuvir
Substance Name:
Ledipasvir; Sofosbuvir
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)].
11-Digit NDC Billing Format:
72626260101
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
2 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1591943 - ledipasvir 90 MG / sofosbuvir 400 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Asegua Therapeutics Llc
    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.
    • Active Ingredient(s):
  • LEDIPASVIR 90 mg/1
  • SOFOSBUVIR 400 mg/1
    • Pharmacologic Class(es):
  • Breast Cancer Resistance Protein Inhibitors - [MoA] (Mechanism of Action)
  • Hepatitis C Virus NS5A Inhibitor - [EPC] (Established Pharmacologic Class)
  • Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Nucleoside Analog - [EXT]
  • P-Glycoprotein Inhibitors - [MoA] (Mechanism of Action)
  • RNA Replicase Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    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 Date:
    12-31-2024
    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 72626-2601-1?

    The NDC Packaged Code 72626-2601-1 is assigned to a 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. The product's dosage form is tablet, film coated and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 2 billable units per package.

    Is NDC 72626-2601 included in the NDC Directory?

    Yes, Ledipasvir And Sofosbuvir with product code 72626-2601 is active and included in the NDC Directory. The product was first marketed by Asegua Therapeutics Llc on January 01, 2019 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 72626-2601-1?

    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 2.

    What is the 11-digit format for NDC 72626-2601-1?

    The 11-digit format is 72626260101. 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 5-4-1 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
    5-4-172626-2601-15-4-272626-2601-01