UROGESIC BLUE
UROGESIC-BLUE™
Approved
Approval ID
f650dd78-615c-42d3-9b2d-3a989039d80c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2023
Manufacturers
FDA
EDWARDS PHARMACEUTICALS, INC.
DUNS: 195118880
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, and HYOSCYAMINE SULFATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0485-0151
Product Classification
G
Generic Name
METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, and HYOSCYAMINE SULFATE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2023
FDA Product Classification
INGREDIENTS (8)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM PHOSPHATE, MONOBASICActive
Quantity: 40.8 mg in 1 1
Code: 3980JIH2SW
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHYLENE BLUEActive
Quantity: 10.8 mg in 1 1
Code: T42P99266K
Classification: ACTIB
METHENAMINEActive
Quantity: 81.6 mg in 1 1
Code: J50OIX95QV
Classification: ACTIB
HYOSCYAMINE SULFATEActive
Quantity: 0.12 mg in 1 1
Code: F2R8V82B84
Classification: ACTIB