Sulfadiazine Tablet
NDC Package 42806-757-60

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

Package Information

Sulfadiazine tablets is a medication used to treat and prevent a wide variety of infections. This formulation utilizes a tablet delivery system. Marketed by Epic Pharma, Llc, this product is identified by NDC 42806-757 and is authorized under FDA application ANDA040091.

Identification & Billing

NDC Package Code
42806-757-60
Package Description
60 TABLET in 1 BOTTLE
Product Code
42806-757
11-Digit Billing Format
42806075760
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sulfadiazine
Non-Proprietary Name
Sulfadiazine
Substance Name
Sulfadiazine
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SULFADIAZINE 500 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat and prevent a wide variety of infections. Sulfadiazine belongs to the class of drugs known as sulfa antibiotics. It works by stopping the growth of bacteria and other organisms. This antibiotic treats only certain types of infections. It will not work for viral infections (e.g., common cold, flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness. This medication should not be used in infants younger than 2 months because of the risk of serious side effects, unless treatment is for a very serious infection (congenital toxoplasmosis).

Regulatory & Marketing

Labeler Name
Epic Pharma, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA040091
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-15-2021
Listing Expiration
12-31-2026
Exclude Flag
N
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 42806-757-60 identifies a specific commercial package of 60 tablet in 1 bottle of Sulfadiazine, a human prescription drug labeled by Epic Pharma, Llc. This tablet is formulated for oral use and contains sulfadiazine 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 Epic Pharma, Llc on December 15, 2021. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat and prevent a wide variety of infections. Sulfadiazine belongs to the class of drugs known as sulfa antibiotics. It works by stopping the growth of bacteria and other organisms. This antibiotic treats only certain types of infections. It will not work for viral infections (e.g., common cold, flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness. This medication should not be used in infants younger than 2 months because of the risk of serious side effects, unless treatment is for a very serious infection (congenital toxoplasmosis).

How is this Epic Pharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42806075760. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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)
42806-757-60
11-Digit CMS (5-4-2)
42806-0757-60

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