Mometasone Furoate Spray, Metered
NDC Package 65162-891-29

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

Package Information

Mometasone Furoate (mometasone) sprays is a medication used to treat skin conditions such as eczema, psoriasis, allergies, and rash. This formulation utilizes a spray, metered delivery system. Marketed by Amneal Pharmaceuticals Llc, this product is identified by NDC 65162-891 and is authorized under FDA application ANDA207989.

Identification & Billing

NDC Package Code
65162-891-29
Package Description
1 BOTTLE, PUMP in 1 CARTON / 120 SPRAY, METERED in 1 BOTTLE, PUMP
Product Code
65162-891
11-Digit Billing Format
65162089129
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
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
Mometasone Furoate
Non-Proprietary Name
Mometasone
Substance Name
Mometasone Furoate
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 50 ug/1
Pharmacologic Class
Usage Information
This medication is used to treat skin conditions such as eczema, psoriasis, allergies, and rash. Mometasone decreases swelling (inflammation), itching, and redness. Mometasone is a medium-strength corticosteroid. This medication is available in several forms including cream, ointment, and lotion (solution). Your doctor will choose the type of product based on the skin condition/area of the body being treated.

Regulatory & Marketing

Labeler Name
Amneal Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA207989
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-04-2017
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 65162-891-29 identifies a specific commercial package of 1 bottle, pump in 1 carton / 120 spray, metered in 1 bottle, pump of Mometasone Furoate, a human prescription drug labeled by Amneal Pharmaceuticals Llc. This spray, metered is formulated for nasal use and contains mometasone furoate 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 Amneal Pharmaceuticals Llc on April 04, 2017. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat skin conditions such as eczema, psoriasis, allergies, and rash. Mometasone decreases swelling (inflammation), itching, and redness. Mometasone is a medium-strength corticosteroid. This medication is available in several forms including cream, ointment, and lotion (solution). Your doctor will choose the type of product based on the skin condition/area of the body being treated.

How is this Amneal Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65162089129. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. 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)
65162-891-29
11-Digit CMS (5-4-2)
65162-0891-29

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