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FDA Approval

URIBEL

CompanyStar Pharmaceuticals, LLC (DUNS: 962184003)

Effective Date

January 24, 2017

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Hexamethylenetetramine(120 mg in 1 1)

Sodium phosphate, dibasic(40.8 mg in 1 1)

Phenyl salicylate(36 mg in 1 1)

Methylene blue(10 mg in 1 1)

Hyoscyamine(0.12 mg in 1 1)

Products (1)

URIBEL

NDC Product Code

0076-0111

Route of Administration

ORAL

Effective Date

January 24, 2017

Ingredients

ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive

Code: L11K75P92JClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

HexamethylenetetramineActive

Code: J50OIX95QVClass: ACTIBQuantity: 120 mg in 1 1

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

Sodium phosphate, dibasicActive

Code: 593YOG76RNClass: ACTIBQuantity: 40.8 mg in 1 1

Phenyl salicylateActive

Code: 28A37T47QOClass: ACTIBQuantity: 36 mg in 1 1

Methylene blueActive

Code: T42P99266KClass: ACTIBQuantity: 10 mg in 1 1

HyoscyamineActive

Code: F2R8V82B84Class: ACTIBQuantity: 0.12 mg in 1 1

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