Budesonide And Formoterol Fumarate Dihydrate
NDC Package 53002-2667-1

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 inactivated by the FDA.

Budesonide And Formoterol Fumarate Dihydrate is the use of budesonide and formoterol fumarate dihydrate is contraindicated in the following conditions: •Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required. Marketed by Rpk Pharmaceuticals, Inc., this product is identified by NDC 53002-2667 and is authorized under FDA application NDA021929.

Identification & Billing

NDC Package Code
53002-2667-1
Package Description
1 POUCH in 1 CARTON / 1 AEROSOL in 1 POUCH
Product Code
53002-2667
11-Digit Billing Format
53002266701
RxNorm Crosswalk
  • RxCUI: 1246304 - budesonide/formoterol fumarate 160/4.5 MCG/INHAL Metered Dose Inhaler, 120 Actuations
  • RxCUI: 1246304 - 120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler
  • RxCUI: 1246304 - budesonide 0.16 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 120 ACTUAT
  • RxCUI: 1246304 - budesonide 160 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUAT

Clinical Specifications

Proprietary Name
Budesonide And Formoterol Fumarate Dihydrate
Dosage Form
-
Usage Information
The use of budesonide and formoterol fumarate dihydrate is contraindicated in the following conditions: •Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required. •Hypersensitivity to any of the ingredients in BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL.

Regulatory & Marketing

Labeler Name
Rpk Pharmaceuticals, Inc.
FDA Application #
NDA021929
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
01-03-2020
Listing Expiration
12-31-2022
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 53002-2667-1 identifies a specific commercial package of 1 pouch in 1 carton / 1 aerosol in 1 pouch of Budesonide And Formoterol Fumarate Dihydrate, labeled by Rpk 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 Rpk Pharmaceuticals, Inc. on January 03, 2020. The current certification is valid through December 31, 2022.

How is this Rpk Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53002266701. 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 (5-4-1)
53002-2667-1
11-Digit CMS (5-4-2)
53002-2667-01

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