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  5. NDC Package Code: 66993-136-97 Fluticasone Furoate And Vilanterol

NDC Package 66993-136-97 Fluticasone Furoate And Vilanterol

Powder Respiratory (inhalation) - 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:
66993-136-97
Package Description:
1 TRAY in 1 CARTON / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER
Product Code:
66993-136
Proprietary Name:
Fluticasone Furoate And Vilanterol
Non-Proprietary Name:
Fluticasone Furoate And Vilanterol
Substance Name:
Fluticasone Furoate; Vilanterol Trifenatate
Usage Information:
The use of Fluticasone Furoate/Vilanterol ELLIPTA is contraindicated in the following conditions:•Primary treatment of status asthmaticus or other acute episodes of COPD or asthma where intensive measures are required [see Warnings and Precautions (5.2)].•Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone furoate, vilanterol, or any of the excipients [see Warnings and Precautions (5.11), Description (11)].
11-Digit NDC Billing Format:
66993013697
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1424889 - fluticasone furoate/vilanterol 100/25 MCG/INHAL Dry Powder Inhaler, 30 Blisters
  • RxCUI: 1424889 - 30 ACTUAT fluticasone furoate 0.1 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler
  • RxCUI: 1648788 - fluticasone furoate/vilanterol 200/25 MCG/INHAL Dry Powder Inhaler, 30 Blisters
  • RxCUI: 1648788 - 30 ACTUAT fluticasone furoate 0.2 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler
  • RxCUI: 1648788 - fluticasone furoate 200 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT (as vilanterol trifenatate 40 MCG/ACTUAT) Dry Powder Inhaler, 30 ACTUAT
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Prasco Laboratories
    Dosage Form:
    Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
    Administration Route(s):
  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
    • Active Ingredient(s):
  • FLUTICASONE FUROATE 200 ug/1
  • VILANTEROL TRIFENATATE 25 ug/1
    • Pharmacologic Class(es):
  • Adrenergic beta2-Agonists - [MoA] (Mechanism of Action)
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)
  • Corticosteroid - [EPC] (Established Pharmacologic Class)
  • beta2-Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA204275
    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:
    05-23-2022
    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 66993-136-97?

    The NDC Packaged Code 66993-136-97 is assigned to a package of 1 tray in 1 carton / 1 inhaler in 1 tray / 30 powder in 1 inhaler of Fluticasone Furoate And Vilanterol, a human prescription drug labeled by Prasco Laboratories. The product's dosage form is powder and is administered via respiratory (inhalation) form.

    Is NDC 66993-136 included in the NDC Directory?

    Yes, Fluticasone Furoate And Vilanterol with product code 66993-136 is active and included in the NDC Directory. The product was first marketed by Prasco Laboratories on May 23, 2022 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 66993-136-97?

    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 1.

    What is the 11-digit format for NDC 66993-136-97?

    The 11-digit format is 66993013697. 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
    5-3-266993-136-975-4-266993-0136-97