Cromolyn Sodium Spray, Metered
NDC Package 57782-397-26

11-digit billing NDC: 57782039726 · Billing unit: ML
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Cromolyn Sodium sprays is •see package insert on how to use pump•parent or care provider must supervise the use of this product by young children•adults and children 2 years and older:•spray once into each nostril. This formulation utilizes a spray, metered delivery system. Marketed by Bausch & Lomb Incorporated, this product is identified by NDC 57782-397 and is authorized under FDA application ANDA075702.

Identification & Billing

NDC Package Code
57782-397-26
Package Description
1 BOTTLE in 1 CARTON / 200 SPRAY, METERED in 1 BOTTLE
Product Code
57782-397
11-Digit Billing Format
57782039726
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
RxCUI: 1797851 - cromolyn sodium 5.2 MG/ACTUAT Metered Dose Nasal Spray

Clinical Specifications

Proprietary Name
Cromolyn Sodium
Non-Proprietary Name
Cromolyn Sodium
Substance Name
Cromolyn Sodium
Dosage Form
Spray, Metered - A non-pressurized dosage form consisting of valves which allow the dispensing of a specified quantity of spray upon each activation.
Administration Route
Nasal - Administration to the nose; administered by way of the nose.
Active Ingredient(s)
CROMOLYN SODIUM 5.2 mg/1
Pharmacologic Class
Usage Information
•see package insert on how to use pump•parent or care provider must supervise the use of this product by young children•adults and children 2 years and older:•spray once into each nostril. Repeat 3-4 times a day (every 4-6 hours). If needed, may be used up to 6 times a day.•use every day while in contact with the cause of your allergies (pollen, molds, pets, and dust)•to prevent nasal allergy symptoms, use before contact with the cause of your allergies. For best results, start using up to one week before contact.•if desired, you can use this product with other medicines, including other allergy medicines.•children under 2 years: Do not use unless directed by a doctor.

Regulatory & Marketing

Labeler Name
Bausch & Lomb Incorporated
Product Type
Human Otc Drug
FDA Application #
ANDA075702
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-03-2001
Listing Expiration
12-31-2027
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 57782-397-26 identifies a specific commercial package of 1 bottle in 1 carton / 200 spray, metered in 1 bottle of Cromolyn Sodium, a human over the counter drug labeled by Bausch & Lomb Incorporated. This spray, metered is formulated for nasal 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 Bausch & Lomb Incorporated on July 03, 2001. The current certification is valid through December 31, 2027.

How is this Bausch & Lomb Incorporated product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57782039726. 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)
57782-397-26
11-Digit CMS (5-4-2)
57782-0397-26

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