Home NDC 50090-5876 Phenazopyridine Hydrochloride
Product NDC 50090-5876
11-digit product format 500905876
Labeler code 50090
Product ID 50090-5876_ab18cf45-4c1d-4d6a-9195-e70ad6e0cd68
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phenazopyridine
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2011-02-01
Substance PHENAZOPYRIDINE HYDROCHLORIDE
Active strength 200 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes NDC auxiliary status# Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date excluded package package 50090-5876 50090-5876-5 D Discontinued by firm 2026-07-31
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions ADVERSE REACTIONS Headache, rash, pruritus and occasional gastrointestinal disturbance. An anaphylactoid-like reaction has been described. Methemoglobinemia, hemolytic anemia, renal and hepatic toxicity have been reported, usually at overdosage levels (see OVERDOSAGE section). To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Additional Listing Data#
Finished product Yes
Brand name base Phenazopyridine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii 0EWG668W17 Rxcui 1094104
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 50090-5876-0 2025-09-05 C162847 48780-1 1030e365-2f87-111a-e063-dadaa90a10e2 PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only 50090-5876-1 2025-09-05 C162847 48780-1 1030e365-2f87-111a-e063-dadaa90a10e2 PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only 50090-5876-4 2025-09-05 C162847 48780-1 1030e365-2f87-111a-e063-dadaa90a10e2 PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only 50090-5876-5 2025-09-05 C162847 48780-1 1030e365-2f87-111a-e063-dadaa90a10e2 PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only 50090-5876-6 2025-09-05 C162847 48780-1 1030e365-2f87-111a-e063-dadaa90a10e2 PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only 50090-5876-7 2025-09-05 C162847 48780-1 1030e365-2f87-111a-e063-dadaa90a10e2 PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only 50090-5876-8 2025-09-05 C162847 48780-1 1030e365-2f87-111a-e063-dadaa90a10e2 PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only 50090-5876-0 2024-01-30 C162847 48780-1 1030e365-2f87-111a-e063-dadaa90a10e2 PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only 50090-5876-1 2024-01-30 C162847 48780-1 1030e365-2f87-111a-e063-dadaa90a10e2 PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only 50090-5876-4 2024-01-30 C162847 48780-1 1030e365-2f87-111a-e063-dadaa90a10e2 PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only 50090-5876-5 2024-01-30 C162847 48780-1 1030e365-2f87-111a-e063-dadaa90a10e2 PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only 50090-5876-6 2024-01-30 C162847 48780-1 1030e365-2f87-111a-e063-dadaa90a10e2 PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only 50090-5876-7 2024-01-30 C162847 48780-1 1030e365-2f87-111a-e063-dadaa90a10e2 PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only 50090-5876-8 2024-01-30 C162847 48780-1 1030e365-2f87-111a-e063-dadaa90a10e2 PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-5876-0 Phenazopyridine Hydrochloride 10 in 1 BOTTLE TABLET 10 6 50090-5876-1 Phenazopyridine Hydrochloride 15 in 1 BOTTLE TABLET 15 6 50090-5876-4 Phenazopyridine Hydrochloride 6 in 1 BOTTLE TABLET 6 6 50090-5876-5 Phenazopyridine Hydrochloride 60 in 1 BOTTLE TABLET 60 6 50090-5876-6 Phenazopyridine Hydrochloride 12 in 1 BOTTLE TABLET 12 6 50090-5876-7 Phenazopyridine Hydrochloride 9 in 1 BOTTLE TABLET 9 6 50090-5876-8 Phenazopyridine Hydrochloride 21 in 1 BOTTLE TABLET 21 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-5876 PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [A-S MEDICATION SOLUTIONS] 3 Current NDC, Legacy NDC, 7 package rows 20220121_d8155f91-d650-4021-91ee-f3b6c1055a36.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50090-5876-0 50090587600 10 TABLET in 1 BOTTLE (50090-5876-0) 10 tablet 2021-12-17 0000-00-00 No No Current 50090-5876-1 50090587601 15 TABLET in 1 BOTTLE (50090-5876-1) 15 tablet 2022-01-20 0000-00-00 No No Current 50090-5876-4 50090587604 6 TABLET in 1 BOTTLE (50090-5876-4) 6 tablet 2022-01-20 0000-00-00 No No Current 50090-5876-5 50090587605 60 TABLET in 1 BOTTLE (50090-5876-5) 60 tablet 2021-12-17 0000-00-00 No No Current 50090-5876-6 50090587606 12 TABLET in 1 BOTTLE (50090-5876-6) 12 tablet 2022-01-20 0000-00-00 No No Current 50090-5876-7 50090587607 9 TABLET in 1 BOTTLE (50090-5876-7) 9 tablet 2022-01-20 0000-00-00 No No Current 50090-5876-8 50090587608 21 TABLET in 1 BOTTLE (50090-5876-8) 21 tablet 2021-12-17 0000-00-00 No No Current