FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
50090-7291
11-digit product format
500907291
Labeler code
50090
Product ID
50090-7291_119badf8-fa86-41c7-b493-63321cac713d
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
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
7e0f2ba8-003c-4303-80fd-76f70ddc2c11Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7291-0Phenazopyridine Hydrochloride10 in 1 BOTTLETABLET101
50090-7291-5Phenazopyridine Hydrochloride12 in 1 BOTTLETABLET121
50090-7291-8Phenazopyridine Hydrochloride6 in 1 BOTTLETABLET61

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7291-0EA - Each50090-7291e763954e-888f-4aa3-90df-0d123cc9288b12024-11-05
50090-7291-5EA - Each50090-729162d26b34-4e95-47ef-8094-16e82bdac37612024-11-05
50090-7291-8EA - Each50090-7291e212c0d7-6b1e-4989-9c5a-a7f265d1315c12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7291PHENAZOPYRIDINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 3 package rows20241015_7e0f2ba8-003c-4303-80fd-76f70ddc2c11.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 Solutions7e0f2ba8-003c-4303-80fd-76f70ddc2c112024-10-14Warnings, Adverse reactionsExact identifier
ndc (product): 50090-7291

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094107phenazopyridine HCl 100 MG Oral TabletPSN7e0f2ba8-003c-4303-80fd-76f70ddc2c111
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD7e0f2ba8-003c-4303-80fd-76f70ddc2c111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7291-05009072910010 TABLET in 1 BOTTLE (50090-7291-0) 10 tablet2024-10-08NoNoCurrent
50090-7291-55009072910512 TABLET in 1 BOTTLE (50090-7291-5) 12 tablet2024-10-08NoNoCurrent
50090-7291-8500907291086 TABLET in 1 BOTTLE (50090-7291-8) 6 tablet2024-10-08NoNoCurrent