Ovaceplus Cream
NDC Package 0178-0495-04

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

Ovaceplus (sulfacetamide sodium) cream is a medication used to treat bacterial eye infections (such as conjunctivitis). This formulation utilizes a cream delivery system. Marketed by Mission Pharmacal Company, this product is identified by NDC 0178-0495.

Identification & Billing

NDC Package Code
0178-0495-04
Package Description
10 TUBE in 1 CARTON / 4 g in 1 TUBE
Product Code
0178-0495
11-Digit Billing Format
00178049504
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ovaceplus Plus
Non-Proprietary Name
Sulfacetamide Sodium
Substance Name
Sulfacetamide Sodium
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route
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)
SULFACETAMIDE SODIUM 100 mg/g
Pharmacologic Class
Usage Information
This medication is used to treat bacterial eye infections (such as conjunctivitis). It belongs to a class of drugs known as sulfa antibiotics. Sulfacetamide works by stopping the growth of bacteria. This medication treats only bacterial eye infections. It will not work for other types of eye infections. Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

Regulatory & Marketing

Labeler Name
Mission Pharmacal Company
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
09-15-2011
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0178-0495). Click a package code to view its specific billing and regulatory data.

0178-0495-02
1 BOTTLE, PLASTIC in 1 CARTON / 57 g in 1 BOTTLE, PLASTIC

* 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 0178-0495-04 identifies a specific commercial package of 10 tube in 1 carton / 4 g in 1 tube of Ovaceplus Plus, a human prescription drug labeled by Mission Pharmacal Company. This cream is formulated for topical use and contains sulfacetamide sodium 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 Mission Pharmacal Company on September 15, 2011. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat bacterial eye infections (such as conjunctivitis). It belongs to a class of drugs known as sulfa antibiotics. Sulfacetamide works by stopping the growth of bacteria. This medication treats only bacterial eye infections. It will not work for other types of eye infections. Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

How is this Mission Pharmacal Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00178049504. 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 (4-4-2)
0178-0495-04
11-Digit CMS (5-4-2)
00178-0495-04

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