MedPath

Sucralfate

2210

Approved
Approval ID

2687d670-8af6-42a2-9081-fee112e80fc0

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 24, 2023

Manufacturers
FDA

Bryant Ranch Prepack

DUNS: 171714327

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 Code63629-1307
Application NumberANDA070848
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sucralfate
Product Specifications
Route of AdministrationORAL
Effective DateMay 24, 2023
FDA Product Classification

INGREDIENTS (4)

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

MedPath

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

© 2025 MedPath, Inc. All rights reserved.

Sucralfate - FDA Drug Approval Details