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  5. NDC Package Code: 76162-134-02 Topcare Allergy

NDC Package 76162-134-02 Topcare Allergy

Mometasone Furoate Monohydrate Spray Nasal - 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:
76162-134-02
Package Description:
1 BOTTLE, SPRAY in 1 CARTON / 120 SPRAY in 1 BOTTLE, SPRAY
Product Code:
76162-134
Proprietary Name:
Topcare Allergy
Non-Proprietary Name:
Mometasone Furoate Monohydrate
Substance Name:
Mometasone Furoate Monohydrate
Usage Information:
Read insert (inside package) for how to:•prime the bottle•use the spray•clean the nozzle•shake well before each use•use this product only once a day•do not use more than directedAdults & children 12 years of age and older•2 sprays in each nostril once daily while sniffing gentlyChildren 2 to 11 years of age•the growth rate of some children may be slower while using this product. Children should use for the shortest amount of time necessary to achieve symptom relief. Talk to your child’s doctor if your child needs to use the spray for longer than two months a year.•an adult should supervise use•1 spray in each nostril once daily while sniffing gentlyChildren under 2 years of age•do not use
11-Digit NDC Billing Format:
76162013402
NDC to RxNorm Crosswalk:
  • RxCUI: 1797865 - mometasone furoate 50 MCG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 1797865 - mometasone furoate 0.05 MG/ACTUAT Metered Dose Nasal Spray
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Topco Associates Llc
    Dosage Form:
    Spray - A liquid minutely divided as by a jet of air or steam.
    Administration Route(s):
  • Nasal - Administration to the nose; administered by way of the nose.
    • Active Ingredient(s):
  • MOMETASONE FUROATE MONOHYDRATE 50 ug/1
    • Pharmacologic Class(es):
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)
  • Corticosteroid - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA215712
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    03-28-2023
    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 76162-134-02?

    The NDC Packaged Code 76162-134-02 is assigned to a package of 1 bottle, spray in 1 carton / 120 spray in 1 bottle, spray of Topcare Allergy, a human over the counter drug labeled by Topco Associates Llc. The product's dosage form is spray and is administered via nasal form.

    Is NDC 76162-134 included in the NDC Directory?

    Yes, Topcare Allergy with product code 76162-134 is active and included in the NDC Directory. The product was first marketed by Topco Associates Llc on March 28, 2023 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 76162-134-02?

    The 11-digit format is 76162013402. 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
    5-3-276162-134-025-4-276162-0134-02