Phosphasal
Phosphasal
Approved
Approval ID
bda27303-2ee9-4a80-b049-7ad514f894e8
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 Code0076-0902
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 (15)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEActive
Quantity: 40.8 mg in 1 1
Code: 593YOG76RN
Classification: ACTIB
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
METHYLENE BLUEActive
Quantity: 10.8 mg in 1 1
Code: T42P99266K
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
METHENAMINEActive
Quantity: 81.6 mg in 1 1
Code: J50OIX95QV
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PHENYL SALICYLATEActive
Quantity: 36.2 mg in 1 1
Code: 28A37T47QO
Classification: ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYOSCYAMINE SULFATEActive
Quantity: 0.12 mg in 1 1
Code: F2R8V82B84
Classification: ACTIB