FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
82804-995
11-digit product format
828040995
Labeler code
82804
Product ID
82804-995_ac155091-ee07-46da-bb25-ff4cd4074610
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, 1094107

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82804-995-00Phenazopyridine Hydrochloride100 in 1 BOTTLETABLET1001
82804-995-06Phenazopyridine Hydrochloride6 in 1 BOTTLETABLET61
82804-995-10Phenazopyridine Hydrochloride10 in 1 BOTTLETABLET101
82804-995-12Phenazopyridine Hydrochloride12 in 1 BOTTLETABLET121
82804-995-20Phenazopyridine Hydrochloride20 in 1 BOTTLETABLET201
82804-995-24Phenazopyridine Hydrochloride24 in 1 BOTTLETABLET241
82804-995-55Phenazopyridine Hydrochloride500 in 1 BOTTLETABLET5001
82804-995-90Phenazopyridine Hydrochloride90 in 1 BOTTLETABLET901
82804-995-96Phenazopyridine Hydrochloride96 in 1 BOTTLETABLET961

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-995-00EA - Each82804-995434e361c-0444-4b4e-97fb-8b85cdf95ade12024-06-10
82804-995-06EA - Each82804-9958a40bc75-1d66-495b-aa15-e1d6c798ce3c12024-06-10
82804-995-10EA - Each82804-995d384c331-be16-4ef1-bcb4-c5503281646b12024-06-10
82804-995-12EA - Each82804-99534e45dff-95c9-4e99-be3c-c97ae063cb5312024-06-10
82804-995-20EA - Each82804-99543e69596-90f6-4376-8a75-f2458e19d81d12024-06-10
82804-995-24EA - Each82804-995e1e8c057-2d00-4eef-969b-2b55f3b9a66112024-06-10
82804-995-55EA - Each82804-9955e32075c-4976-4aaf-ae28-7a3312079fe212024-06-10
82804-995-90EA - Each82804-9953cad2896-4b91-482b-b402-c2d6db37bc4012024-06-10
82804-995-96EA - Each82804-99597c716fd-e893-44bc-a833-d05d58355f5e12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-995PHENAZOPYRIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1Current NDC, 9 package rows20240508_ac155091-ee07-46da-bb25-ff4cd4074610.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094107phenazopyridine HCl 100 MG Oral TabletPSNac155091-ee07-46da-bb25-ff4cd40746101
1094104phenazopyridine HCl 200 MG Oral TabletPSNac155091-ee07-46da-bb25-ff4cd40746101
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCDac155091-ee07-46da-bb25-ff4cd40746101
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCDac155091-ee07-46da-bb25-ff4cd40746101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-995-0082804099500100 TABLET in 1 BOTTLE (82804-995-00) 100 tablet2024-05-06NoNoCurrent
82804-995-06828040995066 TABLET in 1 BOTTLE (82804-995-06) 6 tablet2024-05-06NoNoCurrent
82804-995-108280409951010 TABLET in 1 BOTTLE (82804-995-10) 10 tablet2024-05-06NoNoCurrent
82804-995-128280409951212 TABLET in 1 BOTTLE (82804-995-12) 12 tablet2024-05-06NoNoCurrent
82804-995-208280409952020 TABLET in 1 BOTTLE (82804-995-20) 20 tablet2024-05-06NoNoCurrent
82804-995-248280409952424 TABLET in 1 BOTTLE (82804-995-24) 24 tablet2024-05-06NoNoCurrent
82804-995-5582804099555500 TABLET in 1 BOTTLE (82804-995-55) 500 tablet2024-05-06NoNoCurrent
82804-995-908280409959090 TABLET in 1 BOTTLE (82804-995-90) 90 tablet2024-05-06NoNoCurrent
82804-995-968280409959696 TABLET in 1 BOTTLE (82804-995-96) 96 tablet2024-05-06NoNoCurrent