FDA.reportPublic FDA data

Uristat Ultra

Product NDC
63029-105
11-digit product format
630290105
Labeler code
63029
Product ID
63029-105_14db261b-912d-4675-b681-4162d783ae1d
Type
HUMAN OTC DRUG
Nonproprietary name
Phenazopyridine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Medtech Products Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2018-02-15
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
99.5 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
Uristat Ultra
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENAZOPYRIDINE HYDROCHLORIDE99.5 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
1094147Internal RxNorm lookup
2000033Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c705185f-4908-451e-993b-b0b8a73f0392Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63029-105-12Uristat Ultra12 in 1 BLISTER PACKTABLET124
63029-105-12Uristat Ultra1 in 1 CARTONTABLET14
63029-105-30Uristat Ultra10 in 1 BLISTER PACKTABLET104
63029-105-30Uristat Ultra3 in 1 CARTONTABLET34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63029-105URISTAT ULTRA (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [MEDTECH PRODUCTS INC.]3Current NDC, Legacy NDC, 4 package rows20241215_c705185f-4908-451e-993b-b0b8a73f0392.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
Uristat UltraPHENAZOPYRIDINE HYDROCHLORIDEMedtech Products Inc.c705185f-4908-451e-993b-b0b8a73f03922025-10-23WarningsExact identifier
ndc (product): 63029-105

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094147phenazopyridine HCl 99.5 MG Oral TabletPSNc705185f-4908-451e-993b-b0b8a73f03924
2000033URISTAT ULTRA 99.5 MG Oral TabletPSNc705185f-4908-451e-993b-b0b8a73f03924
2000033phenazopyridine hydrochloride 99.5 MG Oral Tablet [Uristat]SBDc705185f-4908-451e-993b-b0b8a73f03924
1094147phenazopyridine hydrochloride 99.5 MG Oral TabletSCDc705185f-4908-451e-993b-b0b8a73f03924
1094147phenazopyridine HCl 99.5 MG Oral TabletSYc705185f-4908-451e-993b-b0b8a73f03924
2000033Uristat Ultra 99.5 MG Oral TabletSYc705185f-4908-451e-993b-b0b8a73f03924

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63029-105-12630290105121 BLISTER PACK in 1 CARTON (63029-105-12) / 12 TABLET in 1 BLISTER PACK1 blister pack2018-02-150000-00-00NoNoCurrent
63029-105-30630290105303 BLISTER PACK in 1 CARTON (63029-105-30) / 10 TABLET in 1 BLISTER PACK3 blister pack2018-02-150000-00-00NoNoCurrent