Home NDC 82804-047 Phenazopyridine Hydrochloride
Product NDC 82804-047
11-digit product format 828040047
Labeler code 82804
Product ID 82804-047_8c3cb5d2-5e01-4f80-a8b8-70802ac0c8d6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phenazopyridine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Proficient Rx LP
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2023-10-19
Substance PHENAZOPYRIDINE HYDROCHLORIDE
Active strength 100 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Phenazopyridine Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0EWG668W17 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1094107 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82804-047-06 Phenazopyridine Hydrochloride 6 in 1 BOTTLE TABLET 6 2 82804-047-10 Phenazopyridine Hydrochloride 10 in 1 BOTTLE TABLET 10 2 82804-047-12 Phenazopyridine Hydrochloride 12 in 1 BOTTLE TABLET 12 2 82804-047-18 Phenazopyridine Hydrochloride 18 in 1 BOTTLE TABLET 18 2 82804-047-20 Phenazopyridine Hydrochloride 20 in 1 BOTTLE TABLET 20 2 82804-047-24 Phenazopyridine Hydrochloride 24 in 1 BOTTLE TABLET 24 2 82804-047-30 Phenazopyridine Hydrochloride 30 in 1 BOTTLE TABLET 30 2 82804-047-60 Phenazopyridine Hydrochloride 60 in 1 BOTTLE TABLET 60 2 82804-047-90 Phenazopyridine Hydrochloride 90 in 1 BOTTLE TABLET 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82804-047 PHENAZOPYRIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP] 2 Current NDC, 9 package rows 20240216_140a40f8-26ec-46ac-a04b-998ea96e8f93.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82804-047-06 82804004706 6 TABLET in 1 BOTTLE (82804-047-06) 6 tablet 2023-12-20 No No Current 82804-047-10 82804004710 10 TABLET in 1 BOTTLE (82804-047-10) 10 tablet 2023-12-20 No No Current 82804-047-12 82804004712 12 TABLET in 1 BOTTLE (82804-047-12) 12 tablet 2023-12-20 No No Current 82804-047-18 82804004718 18 TABLET in 1 BOTTLE (82804-047-18) 18 tablet 2024-02-14 No No Current 82804-047-20 82804004720 20 TABLET in 1 BOTTLE (82804-047-20) 20 tablet 2023-12-20 No No Current 82804-047-24 82804004724 24 TABLET in 1 BOTTLE (82804-047-24) 24 tablet 2023-12-20 No No Current 82804-047-30 82804004730 30 TABLET in 1 BOTTLE (82804-047-30) 30 tablet 2023-12-20 No No Current 82804-047-60 82804004760 60 TABLET in 1 BOTTLE (82804-047-60) 60 tablet 2023-12-20 No No Current 82804-047-90 82804004790 90 TABLET in 1 BOTTLE (82804-047-90) 90 tablet 2023-12-20 No No Current