Sulfacetamide Sodium And Prednisolone Sodium Phosphate
NDC Package 21695-186-05

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Sulfacetamide Sodium And Prednisolone Sodium Phosphate is ophthalmic solution is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where a superficial bacterial ocular infection or a risk of bacterial ocular infection exists.Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain diminution in edema and inflammation. Marketed by Rebel Distributors Corp, this product is identified by NDC 21695-186 and is authorized under FDA application ANDA074449.

Identification & Billing

NDC Package Code
21695-186-05
Package Description
5 mL in 1 BOTTLE
Product Code
21695-186
11-Digit Billing Format
21695018605
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
5 ML
RxNorm Crosswalk
  • RxCUI: 1012021 - prednisoLONE sodium phosphate 0.25 % / sulfacetamide sodium 10 % Ophthalmic Solution
  • RxCUI: 1012021 - prednisolone sodium phosphate 2.5 MG/ML / sulfacetamide sodium 100 MG/ML Ophthalmic Solution
  • RxCUI: 1012021 - prednisolone sodium phosphate 0.25 % / sulfacetamide sodium 10 % Ophthalmic Solution

Clinical Specifications

Proprietary Name
Sulfacetamide Sodium And Prednisolone Sodium Phosphate
Dosage Form
-
Usage Information
Sulfacetamide sodium and prednisolone sodium phosphate ophthalmic solution is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where a superficial bacterial ocular infection or a risk of bacterial ocular infection exists.Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns or penetration of foreign bodies.The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.The particular antibacterial drug in this product is active against the following common bacterial eye pathogens: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species.The product does not provide adequate coverage against: Neisseria species, Pseudomonas species, Serratia marcescens.A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.

Regulatory & Marketing

Labeler Name
Rebel Distributors Corp
FDA Application #
ANDA074449
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-29-1995
Listing Expiration
12-31-2017
Exclude Flag
I
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 21695-186-05 identifies a specific commercial package of 5 ml in 1 bottle of Sulfacetamide Sodium And Prednisolone Sodium Phosphate, labeled by Rebel Distributors Corp. This product is billed per "ML" milliliter and contains an estimated amount of 5 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Rebel Distributors Corp on December 29, 1995. The current certification is valid through December 31, 2017.

How is this Rebel Distributors Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 21695018605. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 5 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)
21695-186-05
11-Digit CMS (5-4-2)
21695-0186-05

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