Cromolyn Sodium Inhalation Solution
NDC Package 72162-2307-6

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Cromolyn Sodium Inhalation Solution is uSP is a prophylactic agent indicated in the management of patients with bronchial asthma.In patients whose symptoms are sufficiently frequent to require a continuous program of medication, Cromolyn sodium inhalation solution USP is given by inhalation on a regular daily basis (see DOSAGE AND ADMINISTRATION). Marketed by Bryant Ranch Prepack, this product is identified by NDC 72162-2307 and is authorized under FDA application ANDA075437.

Identification & Billing

NDC Package Code
72162-2307-6
Package Description
5 POUCH in 1 CARTON / 12 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE
Product Code
72162-2307
11-Digit Billing Format
72162230706
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Cromolyn Sodium Inhalation Solution
Dosage Form
-
Usage Information
Cromolyn sodium inhalation solution USP is a prophylactic agent indicated in the management of patients with bronchial asthma.In patients whose symptoms are sufficiently frequent to require a continuous program of medication, Cromolyn sodium inhalation solution USP is given by inhalation on a regular daily basis (see DOSAGE AND ADMINISTRATION). The effect of cromolyn sodium is usually evident after several weeks of treatment, although some patients show an almost immediate response.In patients who develop acute bronchoconstriction in response to exposure to exercise, toluene diisocyanate, environmental pollutants, etc., cromolyn sodium should be given shortly before exposure to the precipitating factor (see DOSAGE AND ADMINISTRATION).

Regulatory & Marketing

Labeler Name
Bryant Ranch Prepack
FDA Application #
ANDA075437
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-08-2024
End Marketing Date
09-30-2025
Listing Expiration
09-30-2025
Exclude Flag
D
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 72162-2307-6 identifies a specific commercial package of 5 pouch in 1 carton / 12 vial, single-dose in 1 pouch / 2 ml in 1 vial, single-dose of Cromolyn Sodium Inhalation Solution, labeled by Bryant Ranch Prepack. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Bryant Ranch Prepack on January 08, 2024. The current certification is valid through September 30, 2025.

How is this Bryant Ranch Prepack product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72162230706. 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 (5-4-1)
72162-2307-6
11-Digit CMS (5-4-2)
72162-2307-06

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