URO-PAIN

Product NDC
57237-331
11-digit product format
572370331
Labeler code
57237
Product ID
57237-331_87a9fce7-4a16-4d25-84da-ee961c430efa
Type
HUMAN OTC DRUG
Nonproprietary name
Phenazopyridine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-12-06
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
95 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
URO-PAIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENAZOPYRIDINE HYDROCHLORIDE95 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0EWG668W17
Rxcui1094126

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-331-03URO-PAIN30 in 1 BLISTER PACKTABLET301
57237-331-03URO-PAIN1 in 1 CARTONTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-331URO-PAIN (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [RISING PHARMA HOLDINGS, INC.]1Current NDC, 2 package rows20240113_f0817ef7-c269-4881-81d9-ffc64b404b7e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094126phenazopyridine HCl 95 MG Oral TabletPSNf0817ef7-c269-4881-81d9-ffc64b404b7e1
1094126phenazopyridine hydrochloride 95 MG Oral TabletSCDf0817ef7-c269-4881-81d9-ffc64b404b7e1
1094126phenazopyridine HCl 95 MG Oral TabletSYf0817ef7-c269-4881-81d9-ffc64b404b7e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57237-331-03572370331031 BLISTER PACK in 1 CARTON (57237-331-03) / 30 TABLET in 1 BLISTER PACK1 blister pack2023-12-06NoNoCurrent