Cyclosporine Emulsion
NDC Package 73043-005-01

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

Package Information

Cyclosporine emulsions is cyclosporine is used to prevent organ rejection in people who have received a liver, kidney, or heart transplant. This formulation utilizes a emulsion delivery system. Marketed by Devatis Inc., this product is identified by NDC 73043-005 and is authorized under FDA application ANDA209811.

Identification & Billing

NDC Package Code
73043-005-01
Package Description
3 POUCH in 1 CARTON / 10 VIAL, SINGLE-USE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-USE
Product Code
73043-005
11-Digit Billing Format
73043000501
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cyclosporine
Non-Proprietary Name
Cyclosporine
Substance Name
Cyclosporine
Dosage Form
Emulsion - A dosage form consisting of a two-phase system comprised of at least two immiscible liquids1, one of which is dispersed as droplets (internal or dispersed phase) within the other liquid (external or continuous phase), generally stabilized with one or more emulsifying agents. (Note: Emulsion is used as a dosage form term unless a more specific term is applicable, e.g. cream, lotion, ointment.)
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
CYCLOSPORINE .5 mg/mL
Pharmacologic Class
Usage Information
Cyclosporine is used to prevent organ rejection in people who have received a liver, kidney, or heart transplant. It is usually taken along with other medications to allow your new organ to function normally. Cyclosporine belongs to a class of drugs known as immunosuppressants. It works by weakening the immune system to help your body accept the new organ as if it were your own.

Regulatory & Marketing

Labeler Name
Devatis Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA209811
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-04-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (73043-005). Click a package code to view its specific billing and regulatory data.

73043-005-02
6 POUCH in 1 CARTON / 10 VIAL, SINGLE-USE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-USE

* 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 73043-005-01 identifies a specific commercial package of 3 pouch in 1 carton / 10 vial, single-use in 1 pouch / .4 ml in 1 vial, single-use of Cyclosporine, a human prescription drug labeled by Devatis Inc.. This emulsion is formulated for ophthalmic use and contains cyclosporine 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 Devatis Inc. on July 04, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Cyclosporine is used to prevent organ rejection in people who have received a liver, kidney, or heart transplant. It is usually taken along with other medications to allow your new organ to function normally. Cyclosporine belongs to a class of drugs known as immunosuppressants. It works by weakening the immune system to help your body accept the new organ as if it were your own.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 73043000501. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
73043-005-01
11-Digit CMS (5-4-2)
73043-0005-01

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