Hyoscyamine Sulfate Extended-Release
Hyoscyamine Sulfate Extended-Release Tablets, 0.375 mg PI-9328
Approved
Approval ID
2bf8d44e-e1b2-4a1d-9914-00bb7ef1293e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 17, 2010
Manufacturers
FDA
Carilion Materials Management
DUNS: 079239644
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hyoscyamine Sulfate Extended-Release
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68151-5182
Product Classification
G
Generic Name
Hyoscyamine Sulfate Extended-Release
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 17, 2010
FDA Product Classification
INGREDIENTS (5)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671P
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYOSCYAMINE SULFATEActive
Quantity: 0.375 mg in 1 1
Code: F2R8V82B84
Classification: ACTIB