Probenecid Tablet, Film Coated
NDC Package 0591-5347-77

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

Probenecid tablets is a medication used to prevent gout and gouty arthritis. This formulation utilizes a tablet, film coated delivery system. Marketed by Actavis Pharma, Inc., this product is identified by NDC 0591-5347 and is authorized under FDA application ANDA084442.

Identification & Billing

NDC Package Code
0591-5347-77
Package Description
16812 TABLET, FILM COATED in 1 CONTAINER
Product Code
0591-5347
11-Digit Billing Format
00591534777
RxNorm Crosswalk
RxCUI: 198152 - probenecid 500 MG Oral Tablet

Clinical Specifications

Proprietary Name
Probenecid
Non-Proprietary Name
Probenecid
Substance Name
Probenecid
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
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
Actavis Pharma, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA084442
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-01-1983
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
N/A

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 (0591-5347). Click a package code to view its specific billing and regulatory data.

0591-5347-00
14000 TABLET, FILM COATED in 1 BAG
0591-5347-01
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
0591-5347-10
1000 TABLET, FILM COATED 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 0591-5347-77 identifies a specific commercial package of 16812 tablet, film coated in 1 container of Probenecid, a human prescription drug labeled by Actavis Pharma, Inc.. This tablet, film coated is formulated for oral use and contains probenecid 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 Actavis Pharma, Inc. on July 01, 1983. The current certification is valid through December 31, 2026.

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 Actavis Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00591534777. 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)
0591-5347-77
11-Digit CMS (5-4-2)
00591-5347-77

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