Hyophen
Hyophen
Approved
Approval ID
2c1f0f4c-e57b-4df5-9a58-41d39c3d8893
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 5, 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, Benzoic Acid, Phenyl Salicylate, Methylene Blue, and Hyoscyamine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0076-0901
Product Classification
G
Generic Name
Methenamine, Benzoic Acid, Phenyl Salicylate, Methylene Blue, and Hyoscyamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 5, 2017
FDA Product Classification
INGREDIENTS (16)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
METHENAMINEActive
Quantity: 81.6 mg in 1 1
Code: J50OIX95QV
Classification: ACTIB
PHENYL SALICYLATEActive
Quantity: 36.2 mg in 1 1
Code: 28A37T47QO
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, RICEInactive
Code: 4DGK8B7I3S
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
BENZOIC ACIDActive
Quantity: 9 mg in 1 1
Code: 8SKN0B0MIM
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