Probenecid
NDC Package 43353-839-60

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.

Probenecid is a medication used to prevent gout and gouty arthritis. Marketed by Aphena Pharma Solutions - Tennessee, Llc, this product is identified by NDC 43353-839 and is authorized under FDA application ANDA080966.

Identification & Billing

NDC Package Code
43353-839-60
Package Description
90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
43353-839
11-Digit Billing Format
43353083960
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
90 EA
RxNorm Crosswalk
RxCUI: 198152 - probenecid 500 MG Oral Tablet

Clinical Specifications

Proprietary Name
Probenecid
Dosage Form
-
Usage Information
This medication is used to prevent gout and gouty arthritis. It will not treat a sudden/severe attack of gout and may make it worse. Probenecid belongs to a class of drugs known as uricosurics. It lowers high levels of uric acid in your body by helping the kidneys to get rid of uric acid. When uric acid levels get too high, crystals can form in the joints, causing gout. Lowering uric acid levels may also help your kidneys. Probenecid may be prescribed in combination with certain antibiotics (such as penicillins). It increases the levels of antibiotic in the blood, which helps the antibiotic work better. Probenecid should not be used in children younger than 2 years.

Regulatory & Marketing

Labeler Name
Aphena Pharma Solutions - Tennessee, Llc
FDA Application #
ANDA080966
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-29-1976
Listing Expiration
12-31-2019
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 43353-839-60 identifies a specific commercial package of 90 tablet, film coated in 1 bottle, plastic of Probenecid, labeled by Aphena Pharma Solutions - Tennessee, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 90 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 Aphena Pharma Solutions - Tennessee, Llc on July 29, 1976. The current certification is valid through December 31, 2019.

What are the primary indications for this medication?

This medication is used to prevent gout and gouty arthritis. It will not treat a sudden/severe attack of gout and may make it worse. Probenecid belongs to a class of drugs known as uricosurics. It lowers high levels of uric acid in your body by helping the kidneys to get rid of uric acid. When uric acid levels get too high, crystals can form in the joints, causing gout. Lowering uric acid levels may also help your kidneys. Probenecid may be prescribed in combination with certain antibiotics (such as penicillins). It increases the levels of antibiotic in the blood, which helps the antibiotic work better. Probenecid should not be used in children younger than 2 years.

How is this Aphena Pharma Solutions - Tennessee, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43353083960. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 90 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)
43353-839-60
11-Digit CMS (5-4-2)
43353-0839-60

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