Sulfacetamide Sodium
NDC Package 61314-701-01

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 discontinued by the firm.

Sulfacetamide Sodium is a medication used to treat bacterial eye infections (such as conjunctivitis). Marketed by Sandoz Inc., this product is identified by NDC 61314-701 and is authorized under FDA application ANDA089560.

Identification & Billing

NDC Package Code
61314-701-01
Package Description
15 mL in 1 BOTTLE, PLASTIC
Product Code
61314-701
11-Digit Billing Format
61314070101
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
15 ML

Clinical Specifications

Proprietary Name
Sulfacetamide Sodium
Dosage Form
-
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
Sandoz Inc.
FDA Application #
ANDA089560
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-25-2003
End Marketing Date
05-31-2023
Listing Expiration
05-31-2023
Exclude Flag
D
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 61314-701-01 identifies a specific commercial package of 15 ml in 1 bottle, plastic of Sulfacetamide Sodium, labeled by Sandoz Inc.. 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 Sandoz Inc. on March 25, 2003. The current certification is valid through May 31, 2023.

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 Sandoz Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61314070101. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 15 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)
61314-701-01
11-Digit CMS (5-4-2)
61314-0701-01

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