FDA.reportPublic FDA data

URO-PAIN

Product NDC
57237-330
11-digit product format
572370330
Labeler code
57237
Product ID
57237-330_033f49f6-f96a-4c44-9c80-fc5d581c3af1
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
99.5 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
Brand name suffix
Maximum Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENAZOPYRIDINE HYDROCHLORIDE99.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0EWG668W17
Rxcui1094147

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-330-21URO-PAINMaximum Strength12 in 1 BLISTER PACKTABLET121
57237-330-21URO-PAINMaximum Strength1 in 1 CARTONTABLET11
57237-330-42URO-PAINMaximum Strength1 in 1 CARTONTABLET11
57237-330-42URO-PAINMaximum Strength24 in 1 BLISTER PACKTABLET241

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-330-21EA - Each57237-3309c1c8ce5-c80b-4e90-b0df-24b1b2cd09a312024-03-12
57237-330-42EA - Each57237-330e2100105-4e0c-42ec-a205-c5305dca01d012024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-330URO-PAIN MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [RISING PHARMA HOLDINGS, INC.]1Current NDC, 4 package rows20240113_a8e51a62-366c-4533-a5a4-7f996f6f6bd0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094147phenazopyridine HCl 99.5 MG Oral TabletPSNa8e51a62-366c-4533-a5a4-7f996f6f6bd01
1094147phenazopyridine hydrochloride 99.5 MG Oral TabletSCDa8e51a62-366c-4533-a5a4-7f996f6f6bd01
1094147phenazopyridine HCl 99.5 MG Oral TabletSYa8e51a62-366c-4533-a5a4-7f996f6f6bd01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57237-330-21572370330211 BLISTER PACK in 1 CARTON (57237-330-21) / 12 TABLET in 1 BLISTER PACK1 blister pack2023-12-06NoNoCurrent
57237-330-42572370330421 BLISTER PACK in 1 CARTON (57237-330-42) / 24 TABLET in 1 BLISTER PACK1 blister pack2023-12-06NoNoCurrent