FDA.reportPublic FDA data

Phenazopyridine HCL

Product NDC
72189-534
11-digit product format
721890534
Labeler code
72189
Product ID
72189-534_4c4a9009-3f2d-649f-e063-6394a90a4229
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine HCL
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-02-07
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENAZOPYRIDINE HYDROCHLORIDE100 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
1094107Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
10cd6fad-1923-ad00-e063-6394a90a9554Available 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
72189-534-06Phenazopyridine HCL6 in 1 BOTTLETABLET62
72189-534-10Phenazopyridine HCL10 in 1 BOTTLETABLET102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-534-06EA - Each72189-534a4531a63-1d41-4ddc-9d7c-7d9d7cb23d2012024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-534PHENAZOPYRIDINE HCL TABLET [DIRECT_RX]1Current NDC, 2 package rows20240208_10cd6fad-1923-ad00-e063-6394a90a9554.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_Rx10cd6fad-1923-ad00-e063-6394a90a95542026-03-05Warnings, Adverse reactionsExact identifier
ndc (product): 72189-534

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094107phenazopyridine HCl 100 MG Oral TabletPSN10cd6fad-1923-ad00-e063-6394a90a95542
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD10cd6fad-1923-ad00-e063-6394a90a95542

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-534-06721890534066 TABLET in 1 BOTTLE (72189-534-06) 6 tablet2024-02-07NoNoCurrent
72189-534-107218905341010 TABLET in 1 BOTTLE (72189-534-10) 10 tablet2024-02-07NoNoCurrent