Budesonide And Formoterol Fumarate Dihydrate
NDC Package 70518-3107-0

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.

Budesonide And Formoterol Fumarate Dihydrate is a . Marketed by Remedyrepack Inc., this product is identified by NDC 70518-3107 and is authorized under FDA application NDA021929.

Identification & Billing

NDC Package Code
70518-3107-0
Package Description
1 POUCH in 1 CARTON / 1 CANISTER in 1 POUCH / 120 AEROSOL in 1 CANISTER
Product Code
70518-3107
11-Digit Billing Format
70518310700

Clinical Specifications

Proprietary Name
Budesonide And Formoterol Fumarate Dihydrate
Dosage Form
-

Regulatory & Marketing

Labeler Name
Remedyrepack 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
05-27-2021
End Marketing Date
05-27-2021
Listing Expiration
05-27-2021
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 70518-3107-0 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, labeled by Remedyrepack 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 Remedyrepack Inc. on May 27, 2021. The current certification is valid through May 27, 2021.

How is this Remedyrepack Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70518310700. 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)
70518-3107-0
11-Digit CMS (5-4-2)
70518-3107-00

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