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  5. NDC Package Code: 0093-3609-82 Fluticasone Propionate And Salmeterol

NDC Package 0093-3609-82 Fluticasone Propionate And Salmeterol

Powder, Metered 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:
0093-3609-82
Package Description:
1 POUCH in 1 CARTON / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER
Product Code:
0093-3609
Proprietary Name:
Fluticasone Propionate And Salmeterol
Non-Proprietary Name:
Fluticasone Propionate And Salmeterol
Substance Name:
Fluticasone Propionate; Salmeterol Xinafoate
Usage Information:
Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler (FS MDPI) is indicated for the treatment of asthma in patients aged 12 years and older. Fluticasone Propionate/Salmeterol MDPI should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta2 adrenergic agonist (LABA).Limitations of Use:Fluticasone Propionate/Salmeterol MDPI is NOT indicated for the relief of acute bronchospasm.
11-Digit NDC Billing Format:
00093360982
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: 1918194 - fluticasone propionate/salmeterol 113/14 MCG/INHAL Dry Powder Inhaler, 60 Actuations
  • RxCUI: 1918194 - 60 ACTUAT fluticasone propionate 0.113 MG/ACTUAT / salmeterol 0.014 MG/ACTUAT Dry Powder Inhaler
  • RxCUI: 1918194 - fluticasone propionate 113 MCG/ACTUAT / salmeterol xinafoate 14 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUATS
  • RxCUI: 1918203 - fluticasone propionate/salmeterol 232/14 MCG/INHAL Dry Powder Inhaler, 60 Actuations
  • RxCUI: 1918203 - 60 ACTUAT fluticasone propionate 0.232 MG/ACTUAT / salmeterol 0.014 MG/ACTUAT Dry Powder Inhaler
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Teva Pharmaceuticals Usa, Inc.
    Dosage Form:
    Powder, Metered - An powder dosage form that is situated inside a container that has a mechanism to deliver a specified quantity.
    Administration Route(s):
  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
    • Active Ingredient(s):
  • FLUTICASONE PROPIONATE 232 ug/1
  • SALMETEROL XINAFOATE 14 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:
    NDA208799
    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:
    04-28-2017
    Listing Expiration Date:
    12-31-2025
    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 0093-3609-82?

    The NDC Packaged Code 0093-3609-82 is assigned to a package of 1 pouch in 1 carton / 1 inhaler in 1 pouch / 60 powder, metered in 1 inhaler of Fluticasone Propionate And Salmeterol, a human prescription drug labeled by Teva Pharmaceuticals Usa, Inc.. The product's dosage form is powder, metered and is administered via respiratory (inhalation) form.

    Is NDC 0093-3609 included in the NDC Directory?

    Yes, Fluticasone Propionate And Salmeterol with product code 0093-3609 is active and included in the NDC Directory. The product was first marketed by Teva Pharmaceuticals Usa, Inc. on April 28, 2017 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0093-3609-82?

    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 0093-3609-82?

    The 11-digit format is 00093360982. 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 4-4-2 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
    4-4-20093-3609-825-4-200093-3609-82