Home NDC 60846-501 Pyridium
Product NDC 60846-501
11-digit product format 608460501
Labeler code 60846
Product ID 60846-501_660bbb22-af0c-4025-949d-4681cd4147e1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phenazopyridine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2014-01-01
Substance PHENAZOPYRIDINE HYDROCHLORIDE
Active strength 100 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Pyridium
Listing expiration 2026-12-31 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1094104 Internal RxNorm lookup 1094107 Internal RxNorm lookup 1094109 Internal RxNorm lookup 1094122 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 60846-501-01 Pyridium 100 in 1 BOTTLE TABLET, FILM COATED 100 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PHENAZOPYRIDINE HYDROCHLORIDE ACTIVE INGREDIENT 0EWG668W17 PYRIDIUM (PHENAZOPYRIDINE) TABLET, FILM COATED [GEMINI LABORATORIES, LLC] 5 PHENAZOPYRIDINE ACTIVE MOIETY K2J09EMJ52 PYRIDIUM (PHENAZOPYRIDINE) TABLET, FILM COATED [GEMINI LABORATORIES, LLC] 5 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ PYRIDIUM (PHENAZOPYRIDINE) TABLET, FILM COATED [GEMINI LABORATORIES, LLC] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PYRIDIUM (PHENAZOPYRIDINE) TABLET, FILM COATED [GEMINI LABORATORIES, LLC] 5 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 PYRIDIUM (PHENAZOPYRIDINE) TABLET, FILM COATED [GEMINI LABORATORIES, LLC] 5 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PYRIDIUM (PHENAZOPYRIDINE) TABLET, FILM COATED [GEMINI LABORATORIES, LLC] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PYRIDIUM (PHENAZOPYRIDINE) TABLET, FILM COATED [GEMINI LABORATORIES, LLC] 5 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PYRIDIUM (PHENAZOPYRIDINE) TABLET, FILM COATED [GEMINI LABORATORIES, LLC] 5 POVIDONES INACTIVE INGREDIENT FZ989GH94E PYRIDIUM (PHENAZOPYRIDINE) TABLET, FILM COATED [GEMINI LABORATORIES, LLC] 5 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PYRIDIUM (PHENAZOPYRIDINE) TABLET, FILM COATED [GEMINI LABORATORIES, LLC] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60846-501 PYRIDIUM (PHENAZOPYRIDINE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS LLC] 15 Current NDC, Legacy NDC, 1 package rows 20240216_165d01d4-a9f7-2293-e054-00144ff8d46c.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 Marketing start Marketing end Sample Exclude flag Status 60846-501-01 60846050101 100 TABLET, FILM COATED in 1 BOTTLE (60846-501-01) 2014-01-01 0000-00-00 No No Current