Mometasone Furoate Monohydrate Spray, Metered
NDC Package 70436-154-21

11-digit billing NDC: 70436015421
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Mometasone Furoate Monohydrate sprays is 1.1 Prophylaxis of Seasonal Allergic RhinitisMometasone furoate monohydrate nasal spray is indicated for the prophylaxis of the nasal symptoms of seasonal allergic rhinitis in adult and pediatric patients 12 years and older.1.2 Treatment of Chronic Rhinosinusitis with Nasal PolypsMometasone furoate monohydrate nasal spray is indicated for the treatment of chronic rhinosinusitis with nasal polyps in adult patients 18 years of age and older. This formulation utilizes a spray, metered delivery system. Marketed by Slate Run Pharmaceuticals, Llc., this product is identified by NDC 70436-154 and is authorized under FDA application ANDA211706.

Identification & Billing

NDC Package Code
70436-154-21
Package Description
1 BOTTLE, PUMP in 1 CARTON / 120 SPRAY, METERED in 1 BOTTLE, PUMP
Product Code
70436-154
11-Digit Billing Format
70436015421

Clinical Specifications

Proprietary Name
Mometasone Furoate Monohydrate
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 .05 mg/1
Pharmacologic Class
Usage Information
1.1 Prophylaxis of Seasonal Allergic RhinitisMometasone furoate monohydrate nasal spray is indicated for the prophylaxis of the nasal symptoms of seasonal allergic rhinitis in adult and pediatric patients 12 years and older.1.2 Treatment of Chronic Rhinosinusitis with Nasal PolypsMometasone furoate monohydrate nasal spray is indicated for the treatment of chronic rhinosinusitis with nasal polyps in adult patients 18 years of age and older.

Regulatory & Marketing

Labeler Name
Slate Run Pharmaceuticals, Llc.
Product Type
Human Prescription Drug
FDA Application #
ANDA211706
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-31-2026
Listing Expiration
12-31-2027
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 70436-154-21 identifies a specific commercial package of 1 bottle, pump in 1 carton / 120 spray, metered in 1 bottle, pump of Mometasone Furoate Monohydrate, a human prescription drug labeled by Slate Run Pharmaceuticals, 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 Slate Run Pharmaceuticals, Llc. on October 31, 2026. The current certification is valid through December 31, 2027.

How is this Slate Run Pharmaceuticals, Llc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70436015421. 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)
70436-154-21
11-Digit CMS (5-4-2)
70436-0154-21

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