Probenecid Tablet, Film Coated
NDC Package 0591-5347-10

11-digit billing NDC: 00591534710 · Billing unit: EA · 1000 EA per package
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Probenecid tablets is for treatment of the hyperuricemia associated with gout and gouty arthritis.As an adjuvant to therapy with penicillin or with ampicillin, methicillin, oxacillin, cloxacillin, or nafcillin, for elevation and prolongation of plasma levels by whatever route the antibiotic is given. 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
0591-5347-10
Package Description
1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
0591-5347
11-Digit Billing Format
00591534710
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1000 EA
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
For treatment of the hyperuricemia associated with gout and gouty arthritis.As an adjuvant to therapy with penicillin or with ampicillin, methicillin, oxacillin, cloxacillin, or nafcillin, for elevation and prolongation of plasma levels by whatever route the antibiotic is given.

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
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.

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
0591-5347-77
16812 TABLET, FILM COATED in 1 CONTAINER

* 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 0591-5347-10 identifies a specific commercial package of 1000 tablet, film coated in 1 bottle, plastic 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.

How is this Actavis Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00591534710. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1000 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 (4-4-2)
0591-5347-10
11-Digit CMS (5-4-2)
00591-5347-10

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