Budesonide And Formoterol Fumarate Dihydrate Aerosol
NDC Package 85766-113-12

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

Package Information

Budesonide And Formoterol Fumarate Dihydrate aerosols 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.Hypersensitivity to any of the ingredients in BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL. This formulation utilizes a aerosol delivery system. Marketed by Sportpharm Llc, this product is identified by NDC 85766-113 and is authorized under FDA application NDA021929.

Identification & Billing

NDC Package Code
85766-113-12
Package Description
1 POUCH in 1 CARTON / 1 CANISTER in 1 POUCH / 120 AEROSOL in 1 CANISTER
Product Code
85766-113
11-Digit Billing Format
85766011312
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
  • RxCUI: 1246304 - budesonide/formoterol fumarate 160/4.5 MCG/INHAL Metered Dose Inhaler, 120 Actuations

Clinical Specifications

Proprietary Name
Budesonide And Formoterol Fumarate Dihydrate
Non-Proprietary Name
Budesonide And Formoterol Fumarate Dihydrate
Substance Name
Budesonide; Formoterol Fumarate
Dosage Form
Aerosol - A product that is packaged under pressure and contains therapeutically active ingredients that are released upon activation of an appropriate valve system; it is intended for topical application to the skin as well as local application into the nose (nasal aerosols), mouth (lingual aerosols), or lungs (inhalation aerosols).
Administration Route
Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Active Ingredient(s)
Pharmacologic Class
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
Sportpharm Llc
Product Type
Human Prescription Drug
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
12-31-2027
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 85766-113-12 identifies a specific commercial package of 1 pouch in 1 carton / 1 canister in 1 pouch / 120 aerosol in 1 canister of Budesonide And Formoterol Fumarate Dihydrate, a human prescription drug labeled by Sportpharm Llc. This aerosol is formulated for respiratory (inhalation) use and contains budesonide; formoterol fumarate 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 Sportpharm Llc on January 03, 2020. The current certification is valid through December 31, 2027.

How is this Sportpharm Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85766011312. 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)
85766-113-12
11-Digit CMS (5-4-2)
85766-0113-12

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