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

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 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
1094126Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b11bdb87-4ebc-3a14-e053-2a95a90a7d73Available on FDA.report

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

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 HYDROCHLORIDENuCare Pharmaceuticals,Inc.b11bdb87-4ebc-3a14-e053-2a95a90a7d732024-07-17WarningsExact identifier
ndc (product): 68071-2273

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