Uricalm Tablet, Film Coated
NDC Package 52389-241-28

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

Uricalm (phenazopyridine hydochloride) tablets is read all package directions and warnings before use.Use only as directed.Do not exceed recommended dosage.Adults:  Swallow two (2) tablets with water after meals as needed up to 3 times daily for 2 days maximum.Swallow whole. This formulation utilizes a tablet, film coated delivery system. Marketed by Kobayashi Healthcare International, Inc., this product is identified by NDC 52389-241.

Identification & Billing

NDC Package Code
52389-241-28
Package Description
1 BLISTER PACK in 1 CARTON / 28 TABLET, FILM COATED in 1 BLISTER PACK (52389-241-04)
Product Code
52389-241
11-Digit Billing Format
52389024128
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Uricalm Maximum Strength
Non-Proprietary Name
Phenazopyridine Hydochloride
Substance Name
Phenazopyridine Hydrochloride
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)
PHENAZOPYRIDINE HYDROCHLORIDE 99.5 mg/1
Usage Information
Read all package directions and warnings before use.Use only as directed.Do not exceed recommended dosage.Adults:  Swallow two (2) tablets with water after meals as needed up to 3 times daily for 2 days maximum.Swallow whole. Do not crush or chew.Do not use more than 12 tablets in 2 days.Drink 6 to 8 eight glasses of water daily.For use by normally healthy adults only.  Persons under 18 years of age should use only as directed by a doctor.

Regulatory & Marketing

Labeler Name
Kobayashi Healthcare International, Inc.
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
04-29-2008
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 (52389-241). Click a package code to view its specific billing and regulatory data.

52389-241-12
1 BLISTER PACK in 1 CARTON / 12 TABLET, FILM COATED in 1 BLISTER PACK (52389-241-02)
52389-241-24
1 BLISTER PACK in 1 CARTON / 24 TABLET, FILM COATED in 1 BLISTER PACK (52389-241-01)
52389-241-36
1 BLISTER PACK in 1 CARTON / 36 TABLET, FILM COATED in 1 BLISTER PACK (52389-241-03)
52389-241-48
2 BLISTER PACK in 1 CARTON / 24 TABLET, FILM COATED in 1 BLISTER PACK

* 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 52389-241-28 identifies a specific commercial package of 1 blister pack in 1 carton / 28 tablet, film coated in 1 blister pack (52389-241-04) of Uricalm Maximum Strength, a human over the counter drug labeled by Kobayashi Healthcare International, Inc.. This tablet, film coated is formulated for oral use and contains phenazopyridine hydrochloride 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 Kobayashi Healthcare International, Inc. on April 29, 2008. The current certification is valid through December 31, 2026.

How is this Kobayashi Healthcare International, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52389024128. 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)
52389-241-28
11-Digit CMS (5-4-2)
52389-0241-28

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