Cromolyn Sodium Inhalation Solution
NDC Package 76204-028-60

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Cromolyn Sodium Inhalation Solution is uSP is a prophylactic agent indicated in the management of patients with bronchial asthma.In patients whose symptoms are sufficiently frequent to require a continuous program of medication, cromolyn sodium inhalation solution USP is given by inhalation on a regular daily basis (see DOSAGE AND ADMINISTRATION). Marketed by Ritedose Pharmaceuticals, Llc, this product is identified by NDC 76204-028 and is authorized under FDA application ANDA209453.

Identification & Billing

NDC Package Code
76204-028-60
Package Description
2 POUCH in 1 CARTON / 30 AMPULE in 1 POUCH (76204-028-12) / 2 mL in 1 AMPULE
Product Code
76204-028
11-Digit Billing Format
76204002860
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cromolyn Sodium Inhalation Solution
Dosage Form
-
Usage Information
Cromolyn sodium inhalation solution USP is a prophylactic agent indicated in the management of patients with bronchial asthma.In patients whose symptoms are sufficiently frequent to require a continuous program of medication, cromolyn sodium inhalation solution USP is given by inhalation on a regular daily basis (see DOSAGE AND ADMINISTRATION). The effect of cromolyn sodium is usually evident after several weeks of treatment, although some patients show an almost immediate response. In patients who develop acute bronchoconstriction in response to exposure to exercise, toluene diisocyanate, environmental pollutants, etc., cromolyn sodium should be given shortly before exposure to the precipitating factor (see DOSAGE AND ADMINISTRATION).

Regulatory & Marketing

Labeler Name
Ritedose Pharmaceuticals, Llc
FDA Application #
ANDA209453
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-01-2021
Listing Expiration
12-31-2026
Exclude Flag
I
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J7631
Source: ASP
Cromolyn sodium noncomp unit
HCPCS Dosage 10 MG
Units / Pkg 120

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 76204-028-60 identifies a specific commercial package of 2 pouch in 1 carton / 30 ampule in 1 pouch (76204-028-12) / 2 ml in 1 ampule of Cromolyn Sodium Inhalation Solution, labeled by Ritedose Pharmaceuticals, Llc. 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 Ritedose Pharmaceuticals, Llc on December 01, 2021. The current certification is valid through December 31, 2026.

How is this Ritedose Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76204002860. 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)
76204-028-60
11-Digit CMS (5-4-2)
76204-0028-60

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