Topcare Urinary Pain Relief Tablet
NDC Package 36800-040-30

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

Package Information

Topcare Urinary Pain Relief (phenazopyridine hydrochloride) tablets is ■ Adults and children 12 and over: take 2 tablets 3 times daily with a full glass of water, with or after meals as needed■ Children under 12: consult a doctor■ Do not use for more than 2 days (12 tablets) without consulting a doctor. This formulation utilizes a tablet delivery system. Marketed by Topco Associates Llc, this product is identified by NDC 36800-040.

Identification & Billing

NDC Package Code
36800-040-30
Package Description
1 BLISTER PACK in 1 CARTON / 30 TABLET in 1 BLISTER PACK
Product Code
36800-040
11-Digit Billing Format
36800004030
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Topcare Urinary Pain Relief
Non-Proprietary Name
Phenazopyridine Hydrochloride
Substance Name
Phenazopyridine Hydrochloride
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)
PHENAZOPYRIDINE HYDROCHLORIDE 95 mg/1
Usage Information
■ Adults and children 12 and over: take 2 tablets 3 times daily with a full glass of water, with or after meals as needed■ Children under 12: consult a doctor■ Do not use for more than 2 days (12 tablets) without consulting a doctor

Regulatory & Marketing

Labeler Name
Topco Associates Llc
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
07-01-2013
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 36800-040-30 identifies a specific commercial package of 1 blister pack in 1 carton / 30 tablet in 1 blister pack of Topcare Urinary Pain Relief, a human over the counter drug labeled by Topco Associates Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This tablet 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 Topco Associates Llc on July 01, 2013. The current certification is valid through December 31, 2026.

How is this Topco Associates Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36800004030. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
36800-040-30
11-Digit CMS (5-4-2)
36800-0040-30

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