FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
68071-2479
Requested package NDC
68071-2479-2
11-digit product format
680712479
Labeler code
68071
Product ID
68071-2479_37774bf3-6b23-06e6-e063-6294a90a5966
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-02-01
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
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
2026-12-31

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
c77eb633-9176-17ce-e053-2995a90a3880Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68071-2479-12024-11-15PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only
68071-2479-52024-11-15PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only
68071-2479-12023-01-30PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only
68071-2479-52023-01-30PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2479-1Phenazopyridine Hydrochloride10 in 1 BOTTLETABLET103
68071-2479-2Phenazopyridine Hydrochloride20 in 1 BOTTLETABLET203
68071-2479-3Phenazopyridine Hydrochloride30 in 1 BOTTLETABLET303
68071-2479-5Phenazopyridine Hydrochloride15 in 1 BOTTLETABLET153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2479PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [NUCARE PHARMACEUTICALS,INC.]2Current NDC, Legacy NDC, 4 package rows20241116_c77eb633-9176-17ce-e053-2995a90a3880.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 HydrochloridePHENAZOPYRIDINENuCare Pharmaceuticals,Inc.c77eb633-9176-17ce-e053-2995a90a38802025-06-13Adverse reactionsExact identifier
ndc (package): 68071-2479-2
ndc (product): 68071-2479
ndc11 (package): 68071247902

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094104phenazopyridine HCl 200 MG Oral TabletPSNc77eb633-9176-17ce-e053-2995a90a38803
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCDc77eb633-9176-17ce-e053-2995a90a38803

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-2479-26807124790220 TABLET in 1 BOTTLE (68071-2479-2) 20 tablet2024-11-15NoNoCurrent