Cequa Solution/ Drops
NDC Package 47335-507-97

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

Package Information

Cequa (cyclosporine) solution/ dropses is cyclosporine eye drops are used to treat a certain type of dry eyes. This formulation utilizes a solution/ drops delivery system. Marketed by Sun Pharmaceutical Industries, Inc., this product is identified by NDC 47335-507 and is authorized under FDA application NDA210913.

Identification & Billing

NDC Package Code
47335-507-97
Package Description
1 POUCH in 1 BOX / 10 VIAL, SINGLE-DOSE in 1 POUCH / .25 mL in 1 VIAL, SINGLE-DOSE
Product Code
47335-507
11-Digit Billing Format
47335050797
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cequa
Non-Proprietary Name
Cyclosporine
Substance Name
Cyclosporine
Dosage Form
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route
  • Ophthalmic - Administration to the external eye.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
CYCLOSPORINE .0009 mg/mL
Pharmacologic Class
Usage Information
Cyclosporine eye drops are used to treat a certain type of dry eyes. They work by increasing the amount of tears you make.

Regulatory & Marketing

Labeler Name
Sun Pharmaceutical Industries, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA210913
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-15-2018
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
Yes

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 47335-507-97 identifies a specific commercial package of 1 pouch in 1 box / 10 vial, single-dose in 1 pouch / .25 ml in 1 vial, single-dose of Cequa, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. This solution/ drops is formulated for ophthalmic; topical 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 Sun Pharmaceutical Industries, Inc. on August 15, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Cyclosporine eye drops are used to treat a certain type of dry eyes. They work by increasing the amount of tears you make.

How is this Sun Pharmaceutical Industries, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 47335050797. 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)
47335-507-97
11-Digit CMS (5-4-2)
47335-0507-97

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