Home NDC 68071-5302 Phenazopyridine Hydrochloride
Product NDC 68071-5302
11-digit product format 680715302
Labeler code 68071
Product ID 68071-5302_548f0d4d-3828-fbc2-e063-6394a90adb8e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phenazopyridine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler NuCare Pharmaceuticals, Inc.
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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68071-5302-4 68071530204 4 TABLET in 1 BOTTLE (68071-5302-4) 4 tablet 2026-06-18 No No Current