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  5. NDC Package Code: 50881-027-01 Pemazyre

NDC Package 50881-027-01 Pemazyre

Pemigatinib Tablet 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:
50881-027-01
Package Description:
14 TABLET in 1 BOTTLE, PLASTIC
Product Code:
50881-027
Proprietary Name:
Pemazyre
Non-Proprietary Name:
Pemigatinib
Substance Name:
Pemigatinib
Usage Information:
PEMAZYRE is indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test [see Dosage and Administration (2.1)]. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
11-Digit NDC Billing Format:
50881002701
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
14 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 2359334 - pemigatinib 13.5 MG Oral Tablet
  • RxCUI: 2359340 - Pemazyre 13.5 MG Oral Tablet
  • RxCUI: 2359340 - pemigatinib 13.5 MG Oral Tablet [Pemazyre]
  • RxCUI: 2359342 - pemigatinib 4.5 MG Oral Tablet
  • RxCUI: 2359344 - Pemazyre 4.5 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Incyte Corporation
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • PEMIGATINIB 9 mg/1
    • Pharmacologic Class(es):
  • Kinase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Kinase Inhibitors - [MoA] (Mechanism of Action)
  • Multidrug and Toxin Extrusion Transporter 1 Inhibitors - [MoA] (Mechanism of Action)
  • Organic Cation Transporter 2 Inhibitors - [MoA] (Mechanism of Action)
  • P-Glycoprotein Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA213736
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    04-17-2020
    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 50881-027-01?

    The NDC Packaged Code 50881-027-01 is assigned to a package of 14 tablet in 1 bottle, plastic of Pemazyre, a human prescription drug labeled by Incyte Corporation. The product's dosage form is tablet and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 14 billable units per package.

    Is NDC 50881-027 included in the NDC Directory?

    Yes, Pemazyre with product code 50881-027 is active and included in the NDC Directory. The product was first marketed by Incyte Corporation on April 17, 2020 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 50881-027-01?

    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 14.

    What is the 11-digit format for NDC 50881-027-01?

    The 11-digit format is 50881002701. 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 5-3-2 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
    5-3-250881-027-015-4-250881-0027-01