FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
50090-6951
11-digit product format
500906951
Labeler code
50090
Product ID
50090-6951_89bec0b9-5861-4e39-805d-15160bb819e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-10-19
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
200 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 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
d514fd31-feeb-4371-9b28-eec9834a7003Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6951-0Phenazopyridine Hydrochloride9 in 1 BOTTLETABLET93

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6951-0EA - Each50090-6951067d5985-051c-47af-a050-0caf2074538d12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6951PHENAZOPYRIDINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20240113_d514fd31-feeb-4371-9b28-eec9834a7003.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 HYDROCHLORIDEA-S Medication Solutionsd514fd31-feeb-4371-9b28-eec9834a70032025-12-10Warnings, Adverse reactionsExact identifier
ndc (product): 50090-6951

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094104phenazopyridine HCl 200 MG Oral TabletPSNd514fd31-feeb-4371-9b28-eec9834a70033
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCDd514fd31-feeb-4371-9b28-eec9834a70033

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6951-0500906951009 TABLET in 1 BOTTLE (50090-6951-0) 9 tablet2023-12-19NoNoCurrent