Isoproterenol Hydrochloride
NDC Package 54879-039-15

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.

Isoproterenol Hydrochloride is injection is indicated:For mild or transient episodes of heart block that do not require electric shock or pacemaker therapy.For serious episodes of heart block and Adams-Stokes attacks (except when caused by ventricular tachycardia or fibrillation). Marketed by Sti Pharma Llc, this product is identified by NDC 54879-039 and is authorized under FDA application ANDA215542.

Identification & Billing

NDC Package Code
54879-039-15
Package Description
10 VIAL in 1 CARTON / 5 mL in 1 VIAL
Product Code
54879-039
11-Digit Billing Format
54879003915
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Isoproterenol Hydrochloride
Dosage Form
-
Usage Information
Isoproterenol hydrochloride injection is indicated:For mild or transient episodes of heart block that do not require electric shock or pacemaker therapy.For serious episodes of heart block and Adams-Stokes attacks (except when caused by ventricular tachycardia or fibrillation). (see CONTRAINDICATIONS)For use in cardiac arrest until electric shock or pacemaker therapy, the treatments of choice, is available. (see CONTRAINDICATIONS)For bronchospasm occurring during anesthesia.As an adjunct to fluid and electrolyte replacement therapy and the use of other drugs and procedures in the treatment of hypovolemic and septic shock, low cardiac output (hypoperfusion) states, congestive heart failure, and cardiogenic shock. (see WARNINGS)

Regulatory & Marketing

Labeler Name
Sti Pharma Llc
FDA Application #
ANDA215542
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-15-2022
Listing Expiration
12-31-2023
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 54879-039-15 identifies a specific commercial package of 10 vial in 1 carton / 5 ml in 1 vial of Isoproterenol Hydrochloride, labeled by Sti Pharma 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 Sti Pharma Llc on December 15, 2022. The current certification is valid through December 31, 2023.

How is this Sti Pharma Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54879003915. 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)
54879-039-15
11-Digit CMS (5-4-2)
54879-0039-15

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