Isoproterenol Hydrochloride Injection
NDC Package 42571-294-79

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

Package Information

Isoproterenol Hydrochloride injection is uSP is indicated:For mild or transient episodes of heart block that do not require electric shock or pacemaker therapy. This formulation utilizes a injection delivery system. Marketed by Micro Labs Limited, this product is identified by NDC 42571-294 and is authorized under FDA application ANDA210845.

Identification & Billing

NDC Package Code
42571-294-79
Package Description
25 CARTON in 1 CARTON / 5 AMPULE in 1 CARTON (42571-294-78) / 1 mL in 1 AMPULE
Product Code
42571-294
11-Digit Billing Format
42571029479
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Isoproterenol Hydrochloride
Non-Proprietary Name
Isoproterenol Hydrochloride
Substance Name
Isoproterenol Hydrochloride
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
ISOPROTERENOL HYDROCHLORIDE .2 mg/mL
Pharmacologic Class
Usage Information
Isoproterenol hydrochloride injection, USP 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.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
Micro Labs Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA210845
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-01-2021
Listing Expiration
12-31-2026
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 42571-294-79 identifies a specific commercial package of 25 carton in 1 carton / 5 ampule in 1 carton (42571-294-78) / 1 ml in 1 ampule of Isoproterenol Hydrochloride, a human prescription drug labeled by Micro Labs Limited. This injection is formulated for intravenous use and contains isoproterenol hydrochloride 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 Micro Labs Limited on May 01, 2021. The current certification is valid through December 31, 2026.

How is this Micro Labs Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42571029479. 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)
42571-294-79
11-Digit CMS (5-4-2)
42571-0294-79

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