Sucralfate
Sucralfate Oral Suspension
Approved
Approval ID
cbfbe146-5d42-4a55-9050-df2b5581487a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2023
Manufacturers
FDA
VistaPharm, LLC
DUNS: 116743084
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sucralfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66689-305
Application NumberANDA211884
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sucralfate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 12, 2023
FDA Product Classification
INGREDIENTS (11)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SUCRALFATEActive
Quantity: 1 g in 10 mL
Code: XX73205DH5
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT