FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
82804-994
11-digit product format
828040994
Labeler code
82804
Product ID
82804-994_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
100 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 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1094104Internal RxNorm lookup
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
ac155091-ee07-46da-bb25-ff4cd4074610Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82804-994-00Phenazopyridine Hydrochloride100 in 1 BOTTLETABLET1001
82804-994-06Phenazopyridine Hydrochloride6 in 1 BOTTLETABLET61
82804-994-10Phenazopyridine Hydrochloride10 in 1 BOTTLETABLET101
82804-994-12Phenazopyridine Hydrochloride12 in 1 BOTTLETABLET121
82804-994-20Phenazopyridine Hydrochloride20 in 1 BOTTLETABLET201
82804-994-24Phenazopyridine Hydrochloride24 in 1 BOTTLETABLET241
82804-994-55Phenazopyridine Hydrochloride500 in 1 BOTTLETABLET5001
82804-994-90Phenazopyridine Hydrochloride90 in 1 BOTTLETABLET901
82804-994-96Phenazopyridine Hydrochloride96 in 1 BOTTLETABLET961

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-994-00EA - Each82804-994c69af74b-aada-4984-aab7-a5c0c3d2e83f12024-06-10
82804-994-06EA - Each82804-9947e615ad2-bfce-432f-a33e-077430eecdfe12024-06-10
82804-994-10EA - Each82804-994ee86ba0a-b059-4959-a567-59f9d4b44bca12024-06-10
82804-994-12EA - Each82804-994fa3757e2-d2c5-4303-80b5-f54fe559952a12024-06-10
82804-994-20EA - Each82804-994c2e498f9-f709-47d5-8c10-9384df682db612024-06-10
82804-994-24EA - Each82804-9943ce33e7b-9adf-4ea8-9b46-3303c1b71ef512024-06-10
82804-994-55EA - Each82804-994de59334f-70cb-43ba-9bfa-5bdd53133be812024-06-10
82804-994-90EA - Each82804-994e76e6e8e-118b-446d-adc2-ef798d155e5012024-06-10
82804-994-96EA - Each82804-9945dac90a5-972f-46de-9465-086e33fb500712024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-994PHENAZOPYRIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1Current NDC, 9 package rows20240508_ac155091-ee07-46da-bb25-ff4cd4074610.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 LPac155091-ee07-46da-bb25-ff4cd40746102024-05-01Warnings, Adverse reactionsExact identifier
ndc (product): 82804-994

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
82804-994-0082804099400100 TABLET in 1 BOTTLE (82804-994-00) 100 tablet2024-05-06NoNoCurrent
82804-994-06828040994066 TABLET in 1 BOTTLE (82804-994-06) 6 tablet2024-05-06NoNoCurrent
82804-994-108280409941010 TABLET in 1 BOTTLE (82804-994-10) 10 tablet2024-05-06NoNoCurrent
82804-994-128280409941212 TABLET in 1 BOTTLE (82804-994-12) 12 tablet2024-05-06NoNoCurrent
82804-994-208280409942020 TABLET in 1 BOTTLE (82804-994-20) 20 tablet2024-05-06NoNoCurrent
82804-994-248280409942424 TABLET in 1 BOTTLE (82804-994-24) 24 tablet2024-05-06NoNoCurrent
82804-994-5582804099455500 TABLET in 1 BOTTLE (82804-994-55) 500 tablet2024-05-06NoNoCurrent
82804-994-908280409949090 TABLET in 1 BOTTLE (82804-994-90) 90 tablet2024-05-06NoNoCurrent
82804-994-968280409949696 TABLET in 1 BOTTLE (82804-994-96) 96 tablet2024-05-06NoNoCurrent