Isoproterenol Injection, Solution
NDC Package 69097-521-31

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

Package Information

Isoproterenol (isoproterenol hydrochloride) injection is 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). This formulation utilizes a injection, solution delivery system. Marketed by Cipla Usa Inc., this product is identified by NDC 69097-521 and is authorized under FDA application ANDA210322.

Identification & Billing

NDC Package Code
69097-521-31
Package Description
25 AMPULE in 1 CARTON / 1 mL in 1 AMPULE
Product Code
69097-521
11-Digit Billing Format
69097052131
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Isoproterenol
Non-Proprietary Name
Isoproterenol Hydrochloride
Substance Name
Isoproterenol Hydrochloride
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
  • Intracardiac - Administration with the heart.
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
ISOPROTERENOL HYDROCHLORIDE .2 mg/mL
Pharmacologic Class
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
Cipla Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA210322
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-26-2018
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 69097-521-31 identifies a specific commercial package of 25 ampule in 1 carton / 1 ml in 1 ampule of Isoproterenol, a human prescription drug labeled by Cipla Usa Inc.. This injection, solution is formulated for intracardiac; intramuscular; intravenous; subcutaneous 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 Cipla Usa Inc. on June 26, 2018. The current certification is valid through December 31, 2026.

How is this Cipla Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69097052131. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
69097-521-31
11-Digit CMS (5-4-2)
69097-0521-31

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