Sucralfate
Sucralfate Tablets, USP 1 gram
Approved
Approval ID
30c0965a-02a0-46b5-aa09-3f5fb5047b22
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 16, 2023
Manufacturers
FDA
Chartwell RX, LLC
DUNS: 079394054
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 Code62135-436
Application NumberANDA074415
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sucralfate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 16, 2023
FDA Product Classification
INGREDIENTS (4)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SUCRALFATEActive
Quantity: 1 g in 1 1
Code: XX73205DH5
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT