FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
82804-192
11-digit product format
828040192
Labeler code
82804
Product ID
82804-192_b7a5da89-dc52-4b61-8a54-262d0826c635
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-02-01
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
100 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 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
b7a5da89-dc52-4b61-8a54-262d0826c635Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82804-192-12Phenazopyridine Hydrochloride12 in 1 BOTTLETABLET121
82804-192-18Phenazopyridine Hydrochloride18 in 1 BOTTLETABLET181

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-192-12EA - Each82804-19260258a6a-6808-4098-b4f8-73c74700048b12025-05-14
82804-192-18EA - Each82804-192b24d8637-47e3-4735-8a1a-044cc768e98a12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-192PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [PROFICIENT RX LP]1Current NDC, 2 package rows20250210_b7a5da89-dc52-4b61-8a54-262d0826c635.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 HydrochloridePHENAZOPYRIDINEProficient Rx LPb7a5da89-dc52-4b61-8a54-262d0826c6352025-02-01Adverse reactionsExact identifier
ndc (product): 82804-192

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094107phenazopyridine HCl 100 MG Oral TabletPSNb7a5da89-dc52-4b61-8a54-262d0826c6351
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCDb7a5da89-dc52-4b61-8a54-262d0826c6351

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-192-128280401921212 TABLET in 1 BOTTLE (82804-192-12) 12 tablet2025-01-30NoNoCurrent
82804-192-188280401921818 TABLET in 1 BOTTLE (82804-192-18) 18 tablet2025-01-30NoNoCurrent