Sucralfate
Sucralfate Oral Suspension
Approved
Approval ID
0281961f-78f7-4f3c-947f-c7d1c505ad71
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 26, 2021
Manufacturers
FDA
PINNACLE PHARMA LLC
DUNS: 081126970
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 Code81646-101
Application NumberNDA019183
Product Classification
M
Marketing Category
C73605
G
Generic Name
Sucralfate
Product Specifications
Route of AdministrationORAL
Effective DateApril 26, 2021
FDA Product Classification
INGREDIENTS (9)
SUCRALFATEActive
Quantity: 1 g in 10 mL
Code: XX73205DH5
Classification: ACTIB
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
METHYLCELLULOSE, UNSPECIFIEDInactive
Code: Z944H5SN0H
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
FD&C RED NO. 40Inactive
Quantity: 0.004 mg in 10 mL
Code: WZB9127XOA
Classification: IACT