NDC Package 61919-678-10 Phenazopyridine Hydrochloride

Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
61919-678-10
Package Description:
10 TABLET, FILM COATED in 1 BOTTLE
Product Code:
Proprietary Name:
Phenazopyridine Hydrochloride
Non-Proprietary Name:
Phenazopyridine Hydrochloride
Substance Name:
Phenazopyridine Hydrochloride
Usage Information:
Phenazopyridine HCl is indicated for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine HCl for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. Because it provides only symptomatic relief, prompt appropriate treatment of the cause of pain must be instituted and Phenazopyridine HCl should be discontinued when symptoms are controlled.The analgesic action may reduce or eliminate the need for systemic analgesics or narcotics. It is, however, compatible with antibacterial therapy and can help to relieve pain and discomfort during the interval before antibacterial therapy controls the infection. Treatment of a urinary tract infection with Phenazopyridine HCl should not exceed 2 days because there is a lack of evidence that the combined administration of Phenazopyridine HCl and an antibacterial provides greater benefit than administration of the antibacterial alone after 2 days. (See DOSAGE AND ADMINISTRATION section).
11-Digit NDC Billing Format:
61919067810
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
10 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1094104 - phenazopyridine HCl 200 MG Oral Tablet
  • RxCUI: 1094104 - phenazopyridine hydrochloride 200 MG Oral Tablet
  • RxCUI: 1094107 - phenazopyridine HCl 100 MG Oral Tablet
  • RxCUI: 1094107 - phenazopyridine hydrochloride 100 MG Oral Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Direct Rx
    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(s):
  • Oral - Administration to or by way of the mouth.
  • Sample Package:
    No
    Marketing Category:
    UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
    Start Marketing Date:
    05-01-2019
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    61919-678-066 TABLET, FILM COATED in 1 BOTTLE
    61919-678-099 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 61919-678-10?

    The NDC Packaged Code 61919-678-10 is assigned to a package of 10 tablet, film coated in 1 bottle of Phenazopyridine Hydrochloride, a human prescription drug labeled by Direct Rx. The product's dosage form is tablet, film coated and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 10 billable units per package.

    Is NDC 61919-678 included in the NDC Directory?

    Yes, Phenazopyridine Hydrochloride with product code 61919-678 is active and included in the NDC Directory. The product was first marketed by Direct Rx on May 01, 2019 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 61919-678-10?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 10.

    What is the 11-digit format for NDC 61919-678-10?

    The 11-digit format is 61919067810. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-261919-678-105-4-261919-0678-10