URIMAR-T CAPS
URIMAR-T™ CAPS
Approved
Approval ID
cf7c3d65-11d2-49cd-b207-8ccc6a221fe0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 6, 2023
Manufacturers
FDA
Allegis Pharmaceuticals, LLC
DUNS: 792272861
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, monohydrate, phenyl salicylate, methylene blue, and hyoscyamine sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code28595-224
Product Classification
G
Generic Name
methenamine, sodium phosphate, monobasic, monohydrate, phenyl salicylate, methylene blue, and hyoscyamine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 6, 2023
FDA Product Classification
INGREDIENTS (14)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
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
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
METHENAMINEActive
Quantity: 120 mg in 1 1
Code: J50OIX95QV
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEActive
Quantity: 40.8 mg in 1 1
Code: 593YOG76RN
Classification: ACTIB
PHENYL SALICYLATEActive
Quantity: 36.2 mg in 1 1
Code: 28A37T47QO
Classification: ACTIB
METHYLENE BLUEActive
Quantity: 10.8 mg in 1 1
Code: T42P99266K
Classification: ACTIB
HYOSCYAMINE SULFATEActive
Quantity: 0.12 mg in 1 1
Code: F2R8V82B84
Classification: ACTIB