Hyoscyamine Sulfate
Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg PI-9322 Rev 04/09 Rx Only
Approved
Approval ID
dba6c34f-82e4-49fc-bbe3-97eaabaac1d3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 1, 2020
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
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 Code63187-058
Product Classification
G
Generic Name
Hyoscyamine Sulfate
Product Specifications
Route of AdministrationORAL, SUBLINGUAL
Effective DateApril 1, 2020
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HYOSCYAMINE SULFATEActive
Quantity: 0.125 mg in 1 1
Code: F2R8V82B84
Classification: ACTIB