FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
82804-125
11-digit product format
828040125
Labeler code
82804
Product ID
82804-125_d6acdc67-5c3b-4310-9d25-3c9a89234a38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-10-19
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
200 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 Hydrochloride
Listing expiration
2027-12-31

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
6c3adf9f-7179-43b7-8397-4148a9146a2cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82804-125-06Phenazopyridine Hydrochloride6 in 1 BOTTLETABLET64
82804-125-09Phenazopyridine Hydrochloride9 in 1 BOTTLETABLET94
82804-125-10Phenazopyridine Hydrochloride10 in 1 BOTTLETABLET104
82804-125-12Phenazopyridine Hydrochloride12 in 1 BOTTLETABLET124

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-125-06EA - Each82804-12569f33bd0-98e3-46e6-8265-1515b34dd5f512024-08-12
82804-125-09EA - Each82804-125a6a150b3-c443-41f2-aaa9-eaf154be138412024-12-10
82804-125-10EA - Each82804-1252eea2eae-fc91-4fa2-b187-97428236899d12024-12-10
82804-125-12EA - Each82804-1251b20b8e4-3f1f-4640-94dc-697b48149cd712025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-125PHENAZOPYRIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]4Current NDC, 4 package rows20241129_6c3adf9f-7179-43b7-8397-4148a9146a2c.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 HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEProficient Rx LP6c3adf9f-7179-43b7-8397-4148a9146a2c2024-11-01Warnings, Adverse reactionsExact identifier
ndc (product): 82804-125

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094104phenazopyridine HCl 200 MG Oral TabletPSN6c3adf9f-7179-43b7-8397-4148a9146a2c4
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD6c3adf9f-7179-43b7-8397-4148a9146a2c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-125-06828040125066 TABLET in 1 BOTTLE (82804-125-06) 6 tablet2024-07-15NoNoCurrent
82804-125-09828040125099 TABLET in 1 BOTTLE (82804-125-09) 9 tablet2024-08-21NoNoCurrent
82804-125-108280401251010 TABLET in 1 BOTTLE (82804-125-10) 10 tablet2024-10-01NoNoCurrent
82804-125-128280401251212 TABLET in 1 BOTTLE (82804-125-12) 12 tablet2024-11-20NoNoCurrent