FDA.reportPublic FDA data

Sucralfate

Product NDC
68788-8316
11-digit product format
687888316
Labeler code
68788
Product ID
68788-8316_1c33948f-ec14-473c-8356-1e1d7f975465
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sucralfate
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
NDA018333
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2022-12-23
Substance
SUCRALFATE
Active strength
1 g/1
Pharmacologic classes
Aluminum Complex [EPC], Organometallic Compounds [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sucralfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SUCRALFATE1 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXX73205DH5
Rxcui314234

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
01e96ee1-fe82-0132-025c-ec1559bf8b6eProduct name520260127
f9fa5fa8-e047-2182-3e2c-c4a9ec6531cdProduct name320240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8316-1Sucralfate100 in 1 BOTTLETABLET1004
68788-8316-3Sucralfate30 in 1 BOTTLETABLET304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8316-1EA - Each68788-83164572bc17-393c-4077-ba89-a9ba0990516612023-02-06
68788-8316-3EA - Each68788-83165e980374-bd15-41b5-8139-3f1c4de9cc6112023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8316SUCRALFATE TABLET [PREFERRED PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 2 package rows20240816_536b8c00-13ab-4397-a754-63a1c92bf883.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314234sucralfate 1 GM Oral TabletPSN536b8c00-13ab-4397-a754-63a1c92bf8834
314234sucralfate 1000 MG Oral TabletSCD536b8c00-13ab-4397-a754-63a1c92bf8834
314234sucralfate 1 GM Oral TabletSY536b8c00-13ab-4397-a754-63a1c92bf8834

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8316-168788831601100 TABLET in 1 BOTTLE (68788-8316-1) 100 tablet2022-12-230000-00-00NoNoCurrent
68788-8316-36878883160330 TABLET in 1 BOTTLE (68788-8316-3) 30 tablet2022-12-230000-00-00NoNoCurrent