FDA.reportPublic FDA data

Phenazopyridine HCL

Product NDC
72189-530
11-digit product format
721890530
Labeler code
72189
Product ID
72189-530_1cd4c05a-085d-bae9-e063-6394a90a61ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine HCL
Dosage form
TABLET
Route
ORAL
Labeler
Direct Rx
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-01-05
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 HCL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENAZOPYRIDINE HYDROCHLORIDE200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0EWG668W17Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1094104Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0e34badf-c886-08c1-e063-6294a90aeefdAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-530-06Phenazopyridine HCL6 in 1 BOTTLETABLET63
72189-530-09Phenazopyridine HCL9 in 1 BOTTLETABLET93
72189-530-10Phenazopyridine HCL10 in 1 BOTTLETABLET103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-530-06EA - Each72189-530bf33b145-73a5-44f7-b5f8-ad299118a72712024-02-14
72189-530-09EA - Each72189-530e572af58-e4a1-44b0-b83d-ce0959fd0ba412024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-530PHENAZOPYRIDINE HCL TABLET [DIRECT RX]3Current NDC, 3 package rows20240711_0e34badf-c886-08c1-e063-6294a90aeefd.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phenazopyridine HCLPHENAZOPYRIDINE HCLDirect Rx0e34badf-c886-08c1-e063-6294a90aeefd2024-07-09Warnings, Adverse reactionsExact identifier
ndc (product): 72189-530

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094104phenazopyridine HCl 200 MG Oral TabletPSN0e34badf-c886-08c1-e063-6294a90aeefd3
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD0e34badf-c886-08c1-e063-6294a90aeefd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-530-06721890530066 TABLET in 1 BOTTLE (72189-530-06) 6 tablet2024-01-05NoNoCurrent
72189-530-09721890530099 TABLET in 1 BOTTLE (72189-530-09) 9 tablet2024-01-05NoNoCurrent
72189-530-107218905301010 TABLET in 1 BOTTLE (72189-530-10) 10 tablet2024-01-05NoNoCurrent