URELLE
Urinary Antiseptic
Approved
Approval ID
1d80a11c-6f86-403b-85d4-32ec1924dbe9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 13, 2015
Manufacturers
FDA
Meda Pharmaceuticals
DUNS: 051229602
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
hyoscyamine sulfate, methenamine, methylene blue, phenyl salicylate, and sodium phosphate, monobasic, monohydrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0037-6321
Product Classification
G
Generic Name
hyoscyamine sulfate, methenamine, methylene blue, phenyl salicylate, and sodium phosphate, monobasic, monohydrate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 13, 2015
FDA Product Classification
INGREDIENTS (14)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
METHENAMINEActive
Quantity: 81 mg in 1 1
Code: J50OIX95QV
Classification: ACTIB
METHYLENE BLUEActive
Quantity: 10.8 mg in 1 1
Code: T42P99266K
Classification: ACTIB
PHENYL SALICYLATEActive
Quantity: 32.4 mg in 1 1
Code: 28A37T47QO
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEActive
Quantity: 40.8 mg in 1 1
Code: 593YOG76RN
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
HYOSCYAMINE SULFATEActive
Quantity: 0.12 mg in 1 1
Code: F2R8V82B84
Classification: ACTIB