FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
50090-5904
11-digit product format
500905904
Labeler code
50090
Product ID
50090-5904_c1deb89a-7df7-47ec-8c52-0a6cf71a42e3
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

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phenazopyridine HydrochloridePHENAZOPYRIDINEA-S Medication Solutions900222e8-fc92-4d73-b3d5-1636e717bd652025-09-05Adverse reactionsExact identifier

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
IngredientStrength
PHENAZOPYRIDINE HYDROCHLORIDE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0EWG668W17
Rxcui1094104

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5904-0Phenazopyridine Hydrochloride9 in 1 BOTTLETABLET96

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5904-0EA - Each50090-5904fe6b832e-25d1-4846-a3b6-3ae78391d76012022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5904PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [A-S MEDICATION SOLUTIONS]4Current NDC, Legacy NDC, 1 package rows20231125_900222e8-fc92-4d73-b3d5-1636e717bd65.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094104phenazopyridine HCl 200 MG Oral TabletPSN900222e8-fc92-4d73-b3d5-1636e717bd656
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD900222e8-fc92-4d73-b3d5-1636e717bd656

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5904-0500905904009 TABLET in 1 BOTTLE (50090-5904-0) 9 tablet2022-01-140000-00-00NoNoCurrent