Cisatracurium Besylate Injection
NDC Package 72785-0008-6

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

Package Information

Cisatracurium Besylate injection is indicated:as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of ageto provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the ICUto provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and olderLimitations of UseCisatracurium besylate injection is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action. This formulation utilizes a injection delivery system. Marketed by Zydus Lifesciences Limited, this product is identified by NDC 72785-0008 and is authorized under FDA application ANDA212171.

Identification & Billing

NDC Package Code
72785-0008-6
Package Description
10 VIAL in 1 CARTON / 5 mL in 1 VIAL (72785-0008-1)
Product Code
72785-0008
11-Digit Billing Format
72785000806
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cisatracurium Besylate
Non-Proprietary Name
Cisatracurium Besylate
Substance Name
Cisatracurium Besylate
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)
CISATRACURIUM BESYLATE 2 mg/mL
Pharmacologic Class
Usage Information
Cisatracurium besylate injection is indicated:as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of ageto provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the ICUto provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and olderLimitations of UseCisatracurium besylate injection is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action.

Regulatory & Marketing

Labeler Name
Zydus Lifesciences Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA212171
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-12-2020
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 72785-0008-6 identifies a specific commercial package of 10 vial in 1 carton / 5 ml in 1 vial (72785-0008-1) of Cisatracurium Besylate, a human prescription drug labeled by Zydus Lifesciences Limited. This injection is formulated for intravenous use and contains cisatracurium besylate 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 Zydus Lifesciences Limited on February 12, 2020. The current certification is valid through December 31, 2026.

How is this Zydus Lifesciences Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72785000806. 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)
72785-0008-6
11-Digit CMS (5-4-2)
72785-0008-06

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