Sucralfate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 825560733

Effective Date

June 12, 2020

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Sucralfate(1 g in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

59762-0401

Application Number

NDA018333

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

November 20, 2023

Ingredients

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

Code: XX73205DH5Class: ACTIBQuantity: 1 g in 1 1

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQYClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT