MedPath

Sucralfate

SUCRALFATE TABLETS, USPRx only

Approved
Approval ID

04e60cc5-bdce-4b76-9ec4-3c531fec081d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 8, 2010

Manufacturers
FDA

State of Florida DOH Central Pharmacy

DUNS: 829348114

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 Code53808-0797
Application NumberANDA070848
Product Classification
M
Marketing Category
C73584
G
Generic Name
SUCRALFATE
Product Specifications
Route of AdministrationORAL
Effective DateJune 8, 2010
FDA Product Classification

INGREDIENTS (4)

SUCRALFATEActive
Quantity: 1 g in 1 1
Code: XX73205DH5
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Sucralfate - FDA Drug Approval Details