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
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 Identifiers#

Field, Values table
FieldValues
Unii0EWG668W17
Rxcui1094104

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

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 tablet2024-07-15NoNoHistorical
82804-125-09828040125099 TABLET in 1 BOTTLE (82804-125-09) 9 tablet2024-08-21NoNoHistorical
82804-125-108280401251010 TABLET in 1 BOTTLE (82804-125-10) 10 tablet2024-10-01NoNoHistorical
82804-125-128280401251212 TABLET in 1 BOTTLE (82804-125-12) 12 tablet2024-11-20NoNoHistorical