Gastrocrom
NDC Package 18860-678-70

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Gastrocrom is a medication used to treat mastocytosis, a disease that occurs when the body has too many mast cells. Marketed by Jazz Pharmaceuticals, Inc., this product is identified by NDC 18860-678 and is authorized under FDA application NDA020479.

Identification & Billing

NDC Package Code
18860-678-70
Package Description
12 POUCH in 1 CARTON / 8 AMPULE in 1 POUCH / 5 mL in 1 AMPULE
Product Code
18860-678
11-Digit Billing Format
18860067870
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Gastrocrom
Dosage Form
-
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
Jazz Pharmaceuticals, Inc.
FDA Application #
NDA020479
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-01-1996
End Marketing Date
02-28-2019
Listing Expiration
02-28-2019
Exclude Flag
D
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 18860-678-70 identifies a specific commercial package of 12 pouch in 1 carton / 8 ampule in 1 pouch / 5 ml in 1 ampule of Gastrocrom, labeled by Jazz Pharmaceuticals, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Jazz Pharmaceuticals, Inc. on November 01, 1996. The current certification is valid through February 28, 2019.

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 Jazz Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 18860067870. 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)
18860-678-70
11-Digit CMS (5-4-2)
18860-0678-70

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