FDA.reportPublic FDA data

PHENAZOPYRIDINE HYDROCHLORIDE

Product NDC
68071-2273
11-digit product format
680712273
Labeler code
68071
Product ID
68071-2273_1d76957a-bafd-0eb0-e063-6294a90aaadd
Type
HUMAN OTC DRUG
Nonproprietary name
PHENAZOPYRIDINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2013-07-01
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
95 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHENAZOPYRIDINE HYDROCHLORIDEPHENAZOPYRIDINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.b11bdb87-4ebc-3a14-e053-2a95a90a7d732024-07-17WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warning Do not exceed recommended dosage

Additional Listing Data#

Finished product
Yes
Brand name base
PHENAZOPYRIDINE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENAZOPYRIDINE HYDROCHLORIDE95 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0EWG668W17
Rxcui1094126

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2273-3PHENAZOPYRIDINE HYDROCHLORIDE30 in 1 BLISTER PACKTABLET303
68071-2273-3PHENAZOPYRIDINE HYDROCHLORIDE1 in 1 CARTONTABLET13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2273PHENAZOPYRIDINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 2 package rows20240719_b11bdb87-4ebc-3a14-e053-2a95a90a7d73.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094126phenazopyridine HCl 95 MG Oral TabletPSNb11bdb87-4ebc-3a14-e053-2a95a90a7d733
1094126phenazopyridine hydrochloride 95 MG Oral TabletSCDb11bdb87-4ebc-3a14-e053-2a95a90a7d733
1094126phenazopyridine HCl 95 MG Oral TabletSYb11bdb87-4ebc-3a14-e053-2a95a90a7d733

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2273-3680712273031 BLISTER PACK in 1 CARTON (68071-2273-3) / 30 TABLET in 1 BLISTER PACK1 blister pack2020-10-070000-00-00NoNoCurrent