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  5. NDC Package Code: 52015-700-22 Dificid

NDC Package 52015-700-22 Dificid

Fidaxomicin Granule, For Suspension 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:
52015-700-22
Package Description:
1 POUCH in 1 CARTON / 1 BOTTLE, GLASS in 1 POUCH (52015-700-23) / 150 mL in 1 BOTTLE, GLASS (52015-700-21)
Product Code:
52015-700
Proprietary Name:
Dificid
Non-Proprietary Name:
Fidaxomicin
Substance Name:
Fidaxomicin
Usage Information:
This medication is used to treat a severe intestinal condition (C. difficile-associated diarrhea) due to a certain type of bacteria. This condition may rarely occur after taking antibiotics. Symptoms include diarrhea that doesn't stop, stomach/abdominal pain or cramping, and blood/mucus in your stool. Fidaxomicin is known as a macrolide antibiotic. It works by stopping the growth of this bacteria. This antibiotic works in the intestines and is not absorbed by your body. It should only be used to treat this type of intestinal bacterial infection. It will not work for other types of infections, including viral infections (such as common cold, flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.
11-Digit NDC Billing Format:
52015070022
NDC to RxNorm Crosswalk:
  • RxCUI: 1111106 - fidaxomicin 200 MG Oral Tablet
  • RxCUI: 1111110 - DIFICID 200 MG Oral Tablet
  • RxCUI: 1111110 - fidaxomicin 200 MG Oral Tablet [Dificid]
  • RxCUI: 1111110 - Dificid 200 MG Oral Tablet
  • RxCUI: 2279843 - fidaxomicin 40 MG/mL Oral Suspension
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Merck Sharp & Dohme Llc
    Dosage Form:
    Granule, For Suspension - A small medicinal particle or grain made available in its more stable dry form, to be reconstituted with solvent just before dispensing to form a suspension; the granules are so prepared to contain not only the medicinal agent, but the colorants, flavorants, and any other desired pharmaceutic ingredient.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • FIDAXOMICIN 200 mg/5mL
    • Pharmacologic Class(es):
  • Macrolide Antibacterial - [EPC] (Established Pharmacologic Class)
  • Macrolides - [CS]
    • Sample Package:
    No
    FDA Application Number:
    NDA213138
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    02-18-2020
    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 52015-700-22?

    The NDC Packaged Code 52015-700-22 is assigned to a package of 1 pouch in 1 carton / 1 bottle, glass in 1 pouch (52015-700-23) / 150 ml in 1 bottle, glass (52015-700-21) of Dificid, a human prescription drug labeled by Merck Sharp & Dohme Llc. The product's dosage form is granule, for suspension and is administered via oral form.

    Is NDC 52015-700 included in the NDC Directory?

    Yes, Dificid with product code 52015-700 is active and included in the NDC Directory. The product was first marketed by Merck Sharp & Dohme Llc on February 18, 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 11-digit format for NDC 52015-700-22?

    The 11-digit format is 52015070022. 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
    5-3-252015-700-225-4-252015-0700-22