Uro-MP
URO-MP Capsules
Approved
Approval ID
1e1b0dee-1a3b-4846-a212-c9febb3fc17d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 12, 2023
Manufacturers
FDA
Method Pharmaceuticals, LLC
DUNS: 060216698
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, Anhydrous, Phenyl Salicylate, Methylene Blue and Hyoscyamine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code58657-456
Product Classification
G
Generic Name
Methenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue and Hyoscyamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 12, 2023
FDA Product Classification
INGREDIENTS (14)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PHENYL SALICYLATEActive
Quantity: 36 mg in 1 1
Code: 28A37T47QO
Classification: ACTIB
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
METHENAMINEActive
Quantity: 118 mg in 1 1
Code: J50OIX95QV
Classification: ACTIB
METHYLENE BLUEActive
Quantity: 10 mg in 1 1
Code: T42P99266K
Classification: ACTIB
HYOSCYAMINE SULFATEActive
Quantity: 0.12 mg in 1 1
Code: F2R8V82B84
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSActive
Quantity: 40.8 mg in 1 1
Code: KH7I04HPUU
Classification: ACTIB