Home NDC 68788-8695 Phenazopyridine Hydrochloride
Product NDC 68788-8695
11-digit product format 687888695
Labeler code 68788
Product ID 68788-8695_3682822c-56cf-4662-bc92-ab2dccd755e5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phenazopyridine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Preferred Pharmaceuticals Inc
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2024-06-11
Substance PHENAZOPYRIDINE HYDROCHLORIDE
Active strength 200 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
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 200 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 1094104 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68788-8695-1 Phenazopyridine Hydrochloride 15 in 1 BOTTLE TABLET 15 2 68788-8695-9 Phenazopyridine Hydrochloride 9 in 1 BOTTLE TABLET 9 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-8695 PHENAZOPYRIDINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC] 1 Current NDC, 2 package rows 20240619_96308f8c-66e7-486a-a5c0-ee9a133ad051.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 68788-8695-1 68788869501 15 TABLET in 1 BOTTLE (68788-8695-1) 15 tablet 2024-06-11 No No Current 68788-8695-9 68788869509 9 TABLET in 1 BOTTLE (68788-8695-9) 9 tablet 2024-06-11 No No Current