Gastrocrom Liquid
NDC Package 0037-0678-96

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

Package Information

Gastrocrom (cromolyn sodium) liquids is a medication used to treat mastocytosis, a disease that occurs when the body has too many mast cells. This formulation utilizes a liquid delivery system. Marketed by Viatris Specialty Llc, this product is identified by NDC 0037-0678 and is authorized under FDA application NDA020479.

Identification & Billing

NDC Package Code
0037-0678-96
Package Description
12 POUCH in 1 CARTON / 8 AMPULE in 1 POUCH (0037-0678-08) / 5 mL in 1 AMPULE
Product Code
0037-0678
11-Digit Billing Format
00037067896
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
  • RxCUI: 831269 - Gastrocrom 100 MG in 5 mL Concentrate for Oral Solution
  • RxCUI: 831269 - cromolyn sodium 20 MG/ML Oral Solution [Gastrocrom]

Clinical Specifications

Proprietary Name
Gastrocrom
Non-Proprietary Name
Cromolyn Sodium
Substance Name
Cromolyn Sodium
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CROMOLYN SODIUM 20 mg/mL
Pharmacologic Class
Usage Information
This medication is used to treat mastocytosis, a disease that occurs when the body has too many mast cells. These normal body cells release substances (e.g., histamines) that are needed for normal body defense and healing, but when too many mast cells are present, they release too much of these substances. This can lead to symptoms such as diarrhea, stomach/abdominal pain, itching, rash, and flushing. Cromolyn belongs to a class of medications called mast cell stabilizers. It works by preventing mast cells from releasing the substances that can cause these skin and gut problems.

Regulatory & Marketing

Labeler Name
Viatris Specialty Llc
Product Type
Human Prescription Drug
FDA Application #
NDA020479
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-01-2015
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 0037-0678-96 identifies a specific commercial package of 12 pouch in 1 carton / 8 ampule in 1 pouch (0037-0678-08) / 5 ml in 1 ampule of Gastrocrom, a human prescription drug labeled by Viatris Specialty Llc. This liquid 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 Viatris Specialty Llc on May 01, 2015. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat mastocytosis, a disease that occurs when the body has too many mast cells. These normal body cells release substances (e.g., histamines) that are needed for normal body defense and healing, but when too many mast cells are present, they release too much of these substances. This can lead to symptoms such as diarrhea, stomach/abdominal pain, itching, rash, and flushing. Cromolyn belongs to a class of medications called mast cell stabilizers. It works by preventing mast cells from releasing the substances that can cause these skin and gut problems.

How is this Viatris Specialty Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00037067896. 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 (4-4-2)
0037-0678-96
11-Digit CMS (5-4-2)
00037-0678-96

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