Hyoscyamine Sulfate
Hyoscyamine Sulfate Sublingual Tablets, 0.125 mgPI-9322Rev 04/09 Rx Only
Approved
Approval ID
843d2e6f-9110-4b0d-894f-63b1b206b5ec
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 12, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-926
Product Classification
G
Generic Name
Hyoscyamine Sulfate
Product Specifications
Route of AdministrationORAL, SUBLINGUAL
Effective DateJanuary 12, 2010
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYOSCYAMINE SULFATEActive
Quantity: 0.125 mg in 1 1
Code: F2R8V82B84
Classification: ACTIB