FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
72789-288
11-digit product format
727890288
Labeler code
72789
Product ID
72789-288_2e6f3b44-0998-8b14-e063-6294a90afb14
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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

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 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
c1591037-62f4-469f-8bb2-a82e49dfbecfAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72789-288-09Phenazopyridine Hydrochloride9 in 1 BOTTLE, PLASTICTABLET915

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-288-09EA - Each72789-288e069601e-478a-4628-be3a-b68bcea8811812023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-288PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [PD-RX PHARMACEUTICALS, INC.]15Current NDC, Legacy NDC, 1 package rows20250221_c1591037-62f4-469f-8bb2-a82e49dfbecf.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 HydrochloridePHENAZOPYRIDINEPD-Rx Pharmaceuticals, Inc.c1591037-62f4-469f-8bb2-a82e49dfbecf2025-02-18Adverse reactionsExact identifier
ndc (product): 72789-288

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094104phenazopyridine HCl 200 MG Oral TabletPSNc1591037-62f4-469f-8bb2-a82e49dfbecf15
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCDc1591037-62f4-469f-8bb2-a82e49dfbecf15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-288-09727890288099 TABLET in 1 BOTTLE, PLASTIC (72789-288-09) 9 tablet2022-11-180000-00-00NoNoCurrent