Hyoscyamine Sulfate
Hyoscyamine Sulfate Extended-ReleaseTablets, USP 0.375 mg
Approved
Approval ID
3a200492-c460-4b19-ac16-b64493904b88
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 8, 2010
Manufacturers
FDA
Franklin Pharmaceutical LLC
DUNS: 961561581
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
HYOSCYAMINE SULFATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50532-115
Product Classification
G
Generic Name
HYOSCYAMINE SULFATE
Product Specifications
Route of AdministrationORAL
Effective DateApril 8, 2010
FDA Product Classification
INGREDIENTS (7)
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
ETHYLCELLULOSEInactive
Code: 7Z8S9VYZ4B
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Stearic AcidInactive
Code: 4ELV7Z65AP
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
HYOSCYAMINE SULFATEActive
Quantity: 0.375 mg in 1 1
Code: F2R8V82B84
Classification: ACTIB