Hyoscyamine Sulfate
Hyoscyamine Sulfate Sublingual Tablets, 0.125 mgRx Only
Approved
Approval ID
5dd29015-ce42-4d61-a6bc-d9b7a23411b5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 25, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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 Code63629-1031
Product Classification
G
Generic Name
Hyoscyamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 1, 2018
FDA Product Classification
INGREDIENTS (7)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
HYOSCYAMINE SULFATEActive
Quantity: 0.125 mg in 1 1
Code: F2R8V82B84
Classification: ACTIB