Sucralfate
Sucralfate Oral Suspension 1g/10mL
Approved
Approval ID
126487b1-91d1-480c-a774-90ef325f2dbf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 16, 2024
Manufacturers
FDA
Precision Dose, Inc.
DUNS: 035886746
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 Code68094-043
Application NumberNDA019183
Product Classification
M
Marketing Category
C73605
G
Generic Name
Sucralfate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 16, 2024
FDA Product Classification
INGREDIENTS (9)
FD&C Red No. 40Inactive
Quantity: 0.004 mg in 10 mL
Code: WZB9127XOA
Classification: IACT
methylcellulose, unspecifiedInactive
Code: Z944H5SN0H
Classification: IACT
GlycerinInactive
Quantity: 87.92 mg in 10 mL
Code: PDC6A3C0OX
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
microcrystalline cellulose 105Inactive
Code: KO5GYV0DCB
Classification: IACT
METHYLPARABENInactive
Quantity: 1.78 mg in 10 mL
Code: A2I8C7HI9T
Classification: IACT
WaterInactive
Quantity: 618.006 mg in 10 mL
Code: 059QF0KO0R
Classification: IACT
SorbitolInactive
Quantity: 177.62 mg in 10 mL
Code: 506T60A25R
Classification: IACT
SucralfateActive
Quantity: 1 g in 10 mL
Code: XX73205DH5
Classification: ACTIB