FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
68788-8668
11-digit product format
687888668
Labeler code
68788
Product ID
68788-8668_97f3acb5-0a37-43d5-a68d-9dfd78c59f1b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-05-20
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
100 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 HYDROCHLORIDE100 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
1094107Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ce702be2-eec2-4346-965e-f1f6ba342fc9Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8668-1Phenazopyridine Hydrochloride15 in 1 BOTTLETABLET152
68788-8668-6Phenazopyridine Hydrochloride6 in 1 BOTTLETABLET62

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8668-1EA - Each68788-86687fe690ca-b02e-4d32-a5ff-eb79874fb4bd12024-07-12
68788-8668-6EA - Each68788-866885a70815-1952-42e7-8d31-1c532fffacb212024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8668PHENAZOPYRIDINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 2 package rows20240524_ce702be2-eec2-4346-965e-f1f6ba342fc9.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 HYDROCHLORIDEPreferred Pharmaceuticals Inc.ce702be2-eec2-4346-965e-f1f6ba342fc92026-08-14Warnings, Adverse reactionsExact identifier
ndc (product): 68788-8668

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094107phenazopyridine HCl 100 MG Oral TabletPSNce702be2-eec2-4346-965e-f1f6ba342fc92
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCDce702be2-eec2-4346-965e-f1f6ba342fc92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8668-16878886680115 TABLET in 1 BOTTLE (68788-8668-1) 15 tablet2024-05-20NoNoCurrent
68788-8668-6687888668066 TABLET in 1 BOTTLE (68788-8668-6) 6 tablet2024-05-20NoNoCurrent