FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
50090-6442
11-digit product format
500906442
Labeler code
50090
Product ID
50090-6442_98f81a45-8127-40d8-98a9-a250e0054d9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-02-01
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
7aae87e6-92be-4e66-aca1-5be7f24a8c2dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6442-0Phenazopyridine Hydrochloride10 in 1 BOTTLETABLET104
50090-6442-5Phenazopyridine Hydrochloride12 in 1 BOTTLETABLET124
50090-6442-8Phenazopyridine Hydrochloride6 in 1 BOTTLETABLET64

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6442-0EA - Each50090-644204652ff3-e84f-4999-afa2-8f9907c4f95212023-06-06
50090-6442-5EA - Each50090-6442a785f392-7b56-4829-916d-ee618cd201a612023-06-06
50090-6442-8EA - Each50090-6442b5602b6f-7e7b-4168-8230-d4282e6be25912023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6442PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [A-S MEDICATION SOLUTIONS]4Current NDC, 3 package rows20230427_7aae87e6-92be-4e66-aca1-5be7f24a8c2d.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 HydrochloridePHENAZOPYRIDINEA-S Medication Solutions7aae87e6-92be-4e66-aca1-5be7f24a8c2d2023-04-26Adverse reactionsExact identifier
ndc (product): 50090-6442

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094107phenazopyridine HCl 100 MG Oral TabletPSN7aae87e6-92be-4e66-aca1-5be7f24a8c2d4
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD7aae87e6-92be-4e66-aca1-5be7f24a8c2d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6442-05009064420010 TABLET in 1 BOTTLE (50090-6442-0) 10 tablet2023-04-18NoNoCurrent
50090-6442-55009064420512 TABLET in 1 BOTTLE (50090-6442-5) 12 tablet2023-04-18NoNoCurrent
50090-6442-8500906442086 TABLET in 1 BOTTLE (50090-6442-8) 6 tablet2023-04-18NoNoCurrent