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 Identifiers#

Field, Values table
FieldValues
Unii0EWG668W17
Rxcui1094107

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

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