Cromolyn Sodium Solution
NDC Package 51525-0470-9

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

Package Information

Cromolyn Sodium solution is a medication used to treat certain allergic eye conditions (vernal keratoconjunctivitis, vernal conjunctivitis, vernal keratitis). This formulation utilizes a solution delivery system. Marketed by Mylan Pharmaceuticals Inc., this product is identified by NDC 51525-0470 and is authorized under FDA application NDA020479.

Identification & Billing

NDC Package Code
51525-0470-9
Package Description
12 POUCH in 1 CARTON / 8 AMPULE in 1 POUCH (51525-0470-8) / 5 mL in 1 AMPULE
Product Code
51525-0470
11-Digit Billing Format
51525047009
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 831261 - cromolyn sodium 100 MG in 5 mL Concentrate for Oral Solution
  • RxCUI: 831261 - cromolyn sodium 20 MG/ML Oral Solution
  • RxCUI: 831261 - cromolyn sodium 100 MG per 5 ML Concentrate for Oral Solution

Clinical Specifications

Proprietary Name
Cromolyn Sodium
Non-Proprietary Name
Cromolyn Sodium
Substance Name
Cromolyn Sodium
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CROMOLYN SODIUM 100 mg/5mL
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
Mylan Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA020479
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
10-21-2015
End Marketing Date
06-30-2026
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 51525-0470-9 identifies a specific commercial package of 12 pouch in 1 carton / 8 ampule in 1 pouch (51525-0470-8) / 5 ml in 1 ampule of Cromolyn Sodium, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. This solution is formulated for oral 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 Mylan Pharmaceuticals Inc. on October 21, 2015.

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 Mylan Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51525047009. 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)
51525-0470-9
11-Digit CMS (5-4-2)
51525-0470-09

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