Symax SR
Symax -SR
Approved
Approval ID
d1bb2ea1-cde8-4f3b-93b6-04c7a441f453
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 22, 2023
Manufacturers
FDA
Capellon Pharmaceuticals, LLC
DUNS: 124568093
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 Code64543-112
Product Classification
G
Generic Name
Hyoscyamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 22, 2023
FDA Product Classification
INGREDIENTS (9)
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
CALCIUM PHOSPHATEInactive
Code: 97Z1WI3NDX
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
HYOSCYAMINE SULFATEActive
Quantity: 0.375 mg in 1 1
Code: F2R8V82B84
Classification: ACTIB