Ustell
Ustell™
Approved
Approval ID
dc773b57-378b-4650-9bb0-34e6f8c067ab
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 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 Code0076-0903
Product Classification
G
Generic Name
Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, and Hyoscyamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2017
FDA Product Classification
INGREDIENTS (14)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
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
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
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
Drug Labeling Information
WARNINGS SECTION
LOINC: 34071-1Updated: 8/30/2010
WARNINGS
Do not exceed recommended dosage. If rapid pulse, dizziness or blurring of vision occurs discontinue use immediately.