Topcare Allergy Spray, Metered
NDC Package 76162-134-11

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Topcare Allergy (mometasone furoate monohydrate) sprays is 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. This formulation utilizes a spray, metered delivery system. Marketed by Topco Associates Llc, this product is identified by NDC 76162-134 and is authorized under FDA application NDA215712.

Identification & Billing

NDC Package Code
76162-134-11
Package Description
1 BOTTLE, SPRAY in 1 CARTON / 60 SPRAY, METERED in 1 BOTTLE, SPRAY
Product Code
76162-134
11-Digit Billing Format
76162013411
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

Clinical Specifications

Proprietary Name
Topcare Allergy
Non-Proprietary Name
Mometasone Furoate Monohydrate
Substance Name
Mometasone Furoate Monohydrate
Dosage Form
Spray, Metered - A non-pressurized dosage form consisting of valves which allow the dispensing of a specified quantity of spray upon each activation.
Administration Route
Nasal - Administration to the nose; administered by way of the nose.
Active Ingredient(s)
MOMETASONE FUROATE MONOHYDRATE 50 ug/1
Pharmacologic Class
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

Regulatory & Marketing

Labeler Name
Topco Associates Llc
Product Type
Human Otc Drug
FDA Application #
NDA215712
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-28-2023
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (76162-134). Click a package code to view its specific billing and regulatory data.

76162-134-02
1 BOTTLE, SPRAY in 1 CARTON / 120 SPRAY, METERED in 1 BOTTLE, SPRAY

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 76162-134-11 identifies a specific commercial package of 1 bottle, spray in 1 carton / 60 spray, metered in 1 bottle, spray of Topcare Allergy, a human over the counter drug labeled by Topco Associates Llc. This spray, metered is formulated for nasal use and contains mometasone furoate monohydrate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Topco Associates Llc on March 28, 2023. The current certification is valid through December 31, 2026.

How is this Topco Associates Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76162013411. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
76162-134-11
11-Digit CMS (5-4-2)
76162-0134-11

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.