Flunisolide Solution
NDC Package 50742-317-25

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

Package Information

Flunisolide solution is flunisolide is used to prevent and treat seasonal and year-round allergy symptoms (such as stuffy/runny nose, itchy eyes/nose/throat, sneezing). This formulation utilizes a solution delivery system. Marketed by Ingenus Pharmaceuticals, Llc, this product is identified by NDC 50742-317 and is authorized under FDA application ANDA207802.

Identification & Billing

NDC Package Code
50742-317-25
Package Description
1 BOTTLE, PUMP in 1 CARTON / 25 mL in 1 BOTTLE, PUMP
Product Code
50742-317
11-Digit Billing Format
50742031725
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Flunisolide
Non-Proprietary Name
Flunisolide
Substance Name
Flunisolide
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Nasal - Administration to the nose; administered by way of the nose.
Active Ingredient(s)
FLUNISOLIDE .25 mg/mL
Pharmacologic Class
Usage Information
Flunisolide is used to prevent and treat seasonal and year-round allergy symptoms (such as stuffy/runny nose, itchy eyes/nose/throat, sneezing). Flunisolide belongs to a class of drugs known as corticosteroids. It works by reducing swelling (inflammation) in the nasal passages.

Regulatory & Marketing

Labeler Name
Ingenus Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA207802
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-23-2022
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 50742-317-25 identifies a specific commercial package of 1 bottle, pump in 1 carton / 25 ml in 1 bottle, pump of Flunisolide, a human prescription drug labeled by Ingenus Pharmaceuticals, Llc. This solution is formulated for nasal use and contains flunisolide 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 Ingenus Pharmaceuticals, Llc on June 23, 2022. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Flunisolide is used to prevent and treat seasonal and year-round allergy symptoms (such as stuffy/runny nose, itchy eyes/nose/throat, sneezing). Flunisolide belongs to a class of drugs known as corticosteroids. It works by reducing swelling (inflammation) in the nasal passages.

How is this Ingenus Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50742031725. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
50742-317-25
11-Digit CMS (5-4-2)
50742-0317-25

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