Cromolyn Sodium Inhalant
NDC Package 42571-350-50

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

Cromolyn Sodium inhalants is a medication used to treat certain allergic eye conditions (vernal keratoconjunctivitis, vernal conjunctivitis, vernal keratitis). This formulation utilizes a inhalant delivery system. Marketed by Micro Labs Limited, this product is identified by NDC 42571-350 and is authorized under FDA application ANDA213658.

Identification & Billing

NDC Package Code
42571-350-50
Package Description
10 CARTON in 1 CARTON / 12 AMPULE in 1 CARTON / 2 mL in 1 AMPULE (42571-350-08)
Product Code
42571-350
11-Digit Billing Format
42571035050
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cromolyn Sodium
Non-Proprietary Name
Cromolyn Sodium
Substance Name
Cromolyn Sodium
Dosage Form
Inhalant - A special class of inhalations consisting of a drug or combination of drugs, that by virtue of their high vapor pressure can be carried by an air current into the nasal passage where they exert their effect; the container from which the inhalant generally is administered is known as an inhaler.
Administration Route
Intrabronchial - Administration within a bronchus.
Active Ingredient(s)
CROMOLYN SODIUM 20 mg/2mL
Pharmacologic Class
Usage Information
This medication is used to treat certain allergic eye conditions (vernal keratoconjunctivitis, vernal conjunctivitis, vernal keratitis). It prevents itching of the eyes that can occur with these conditions. Cromolyn is known as a mast cell stabilizer. It works by blocking certain natural substances (histamine, SRS-A) that cause allergic symptoms.

Regulatory & Marketing

Labeler Name
Micro Labs Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA213658
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-01-2022
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (42571-350). Click a package code to view its specific billing and regulatory data.

42571-350-09
5 CARTON in 1 CARTON / 12 AMPULE in 1 CARTON / 2 mL in 1 AMPULE (42571-350-08)

* 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 42571-350-50 identifies a specific commercial package of 10 carton in 1 carton / 12 ampule in 1 carton / 2 ml in 1 ampule (42571-350-08) of Cromolyn Sodium, a human prescription drug labeled by Micro Labs Limited. This inhalant is formulated for intrabronchial use and contains cromolyn sodium 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 Micro Labs Limited on June 01, 2022. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat certain allergic eye conditions (vernal keratoconjunctivitis, vernal conjunctivitis, vernal keratitis). It prevents itching of the eyes that can occur with these conditions. Cromolyn is known as a mast cell stabilizer. It works by blocking certain natural substances (histamine, SRS-A) that cause allergic symptoms.

How is this Micro Labs Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42571035050. 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)
42571-350-50
11-Digit CMS (5-4-2)
42571-0350-50

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