FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
70518-3868
Requested package NDC
70518-3868-3
11-digit product format
705183868
Labeler code
70518
Product ID
70518-3868_53e5fcb2-f144-3739-e063-6394a90a5da0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-09-21
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
82dc87bb-ba27-4b86-9bc9-18492975ac9fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3868-0Phenazopyridine Hydrochloride9 in 1 BOTTLE, PLASTICTABLET99
70518-3868-1Phenazopyridine Hydrochloride21 in 1 BOTTLE, PLASTICTABLET219
70518-3868-2Phenazopyridine Hydrochloride6 in 1 BOTTLE, PLASTICTABLET69
70518-3868-3Phenazopyridine Hydrochloride30 in 1 BLISTER PACKTABLET309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3868PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [REMEDYREPACK INC.]7Current NDC, 4 package rows20250309_82dc87bb-ba27-4b86-9bc9-18492975ac9f.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 HydrochloridePHENAZOPYRIDINEREMEDYREPACK INC.82dc87bb-ba27-4b86-9bc9-18492975ac9f2026-06-10Adverse reactionsExact identifier
ndc (package): 70518-3868-3
ndc (product): 70518-3868
ndc11 (package): 70518386803

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094104phenazopyridine HCl 200 MG Oral TabletPSN82dc87bb-ba27-4b86-9bc9-18492975ac9f9
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD82dc87bb-ba27-4b86-9bc9-18492975ac9f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3868-37051838680330 TABLET in 1 BLISTER PACK (70518-3868-3) 30 tablet2025-03-07NoNoCurrent