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  5. NDC Package Code: 53002-2666-1 Budesonide And Formoterol Fumarate Dihydrate

NDC Package 53002-2666-1 Budesonide And Formoterol Fumarate Dihydrate

View Billable Units, 11-Digit Format, RxNorm

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.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
53002-2666-1
Package Description:
1 POUCH in 1 CARTON / 1 AEROSOL in 1 POUCH
Product Code:
53002-2666
Proprietary Name:
Budesonide And Formoterol Fumarate Dihydrate
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.
11-Digit NDC Billing Format:
53002266601
NDC to RxNorm Crosswalk:
  • RxCUI: 1246288 - budesonide/formoterol fumarate 80/4.5 MCG/INHAL Metered Dose Inhaler, 120 Actuations
  • RxCUI: 1246288 - 120 ACTUAT budesonide 0.08 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler
  • RxCUI: 1246288 - budesonide 0.08 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 120 ACTUAT
  • RxCUI: 1246288 - budesonide 80 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUAT
Labeler Name:
Rpk Pharmaceuticals, Inc.
Sample Package:
No
FDA Application Number:
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 Date:
12-31-2024
Exclude Flag:
I
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 53002-2666-1?

The NDC Packaged Code 53002-2666-1 is assigned to a package of 1 pouch in 1 carton / 1 aerosol in 1 pouch of Budesonide And Formoterol Fumarate Dihydrate, labeled by Rpk Pharmaceuticals, Inc.. The product's dosage form is and is administered via form.

Is NDC 53002-2666 included in the NDC Directory?

No, Budesonide And Formoterol Fumarate Dihydrate with product code 53002-2666 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Rpk Pharmaceuticals, Inc. on January 03, 2020 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 53002-2666-1?

The 11-digit format is 53002266601. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-4-153002-2666-15-4-253002-2666-01