Cromolyn Sodium Solution/ Drops
NDC Package 61314-237-10

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/ dropses is a medication used to treat certain allergic eye conditions (vernal keratoconjunctivitis, vernal conjunctivitis, vernal keratitis). This formulation utilizes a solution/ drops delivery system. Marketed by Sandoz Inc, this product is identified by NDC 61314-237 and is authorized under FDA application ANDA075282.

Identification & Billing

NDC Package Code
61314-237-10
Package Description
10 mL in 1 BOTTLE, PLASTIC
Product Code
61314-237
11-Digit Billing Format
61314023710
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
10 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cromolyn Sodium
Non-Proprietary Name
Cromolyn Sodium
Substance Name
Cromolyn Sodium
Dosage Form
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
CROMOLYN SODIUM 40 mg/mL
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
Sandoz Inc
Product Type
Human Prescription Drug
FDA Application #
ANDA075282
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-29-1999
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 61314-237-10 identifies a specific commercial package of 10 ml in 1 bottle, plastic of Cromolyn Sodium, a human prescription drug labeled by Sandoz Inc. This solution/ drops is formulated for ophthalmic 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 Sandoz Inc on June 29, 1999. 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 Sandoz Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61314023710. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 10 total billable units per package. 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)
61314-237-10
11-Digit CMS (5-4-2)
61314-0237-10

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