Blephamide
NDC Package 54868-0634-1

11-digit billing NDC: 54868063401 · Billing unit: ML · 5 ML per package
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.

Blephamide is a steroid/anti-infective combination is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-0634 and is authorized under FDA application NDA012813.

Identification & Billing

NDC Package Code
54868-0634-1
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER
Product Code
54868-0634
11-Digit Billing Format
54868063401
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: 1012015 - sulfacetamide sodium 10 % / prednisoLONE acetate 0.2 % Ophthalmic Suspension
  • RxCUI: 1012015 - prednisolone acetate 2 MG/ML / sulfacetamide sodium 100 MG/ML Ophthalmic Suspension
  • RxCUI: 1012015 - prednisolone acetate 0.2 % / sulfacetamide sodium 10 % Ophthalmic Suspension
  • RxCUI: 1012017 - BLEPHAMIDE 10 % / 0.2 % Ophthalmic Suspension
  • RxCUI: 1012017 - prednisolone acetate 2 MG/ML / sulfacetamide sodium 100 MG/ML Ophthalmic Suspension [Blephamide]

Clinical Specifications

Proprietary Name
Blephamide
Dosage Form
-
Usage Information
A steroid/anti-infective combination is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where 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. This product does not provide adequate coverage against: Neisseria species, Pseudomonas species, and Serratia marcescens. A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA012813
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-01-1961
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 54868-0634-1 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 5 ml in 1 bottle, dropper of Blephamide, labeled by Physicians Total Care, Inc.. 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 Physicians Total Care, Inc. on October 01, 1961. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868063401. 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 (5-4-1)
54868-0634-1
11-Digit CMS (5-4-2)
54868-0634-01

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