Sucralfate
Sucralfate Tablets
Approved
Approval ID
ae58c382-c1cf-4ebf-9c97-bdff0682df8b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 12, 2020
Manufacturers
FDA
Greenstone LLC
DUNS: 825560733
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 Code59762-0401
Application NumberNDA018333
Product Classification
M
Marketing Category
C73605
G
Generic Name
Sucralfate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 20, 2023
FDA Product Classification
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SUCRALFATEActive
Quantity: 1 g in 1 1
Code: XX73205DH5
Classification: ACTIB
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT