URIBEL
Uribel
Approved
Approval ID
fa2cc334-bd86-46cc-bc6a-12c71303f963
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 24, 2017
Manufacturers
FDA
Star Pharmaceuticals, LLC
DUNS: 962184003
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 Code0076-0111
Product Classification
G
Generic Name
Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, and Hyoscyamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 24, 2017
FDA Product Classification
INGREDIENTS (11)
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
METHENAMINEActive
Quantity: 120 mg in 1 1
Code: J50OIX95QV
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEActive
Quantity: 40.8 mg in 1 1
Code: 593YOG76RN
Classification: ACTIB
PHENYL SALICYLATEActive
Quantity: 36 mg in 1 1
Code: 28A37T47QO
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