FDA.reportPublic FDA data

Sucralfate

Product NDC
51079-753
11-digit product format
510790753
Labeler code
51079
Product ID
51079-753_3a87770c-fa4f-d061-e063-6294a90a6751
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sucralfate
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA070848
Marketing category
ANDA
Marketing start
2013-09-24
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
51079-753-01Sucralfate1 in 1 BLISTER PACKTABLET110
51079-753-20Sucralfate100 in 1 CARTONTABLET10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-753-01EA - Each51079-75351b5f197-7818-49b2-9e9c-0f767e237fcf12014-07-02
51079-753-20EA - Each51079-753694f39e8-1962-41bd-9125-7b1e78ea2f8f12014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SUCRALFATEACTIVE INGREDIENTXX73205DH5SUCRALFATE TABLET [CARDINAL HEALTH]1
SUCRALFATEACTIVE INGREDIENTXX73205DH5SUCRALFATE TABLET [MYLAN INSTITUTIONAL INC.]1
SUCRALFATEACTIVE MOIETYXX73205DH5SUCRALFATE TABLET [CARDINAL HEALTH]1
SUCRALFATEACTIVE MOIETYXX73205DH5SUCRALFATE TABLET [MYLAN INSTITUTIONAL INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUCRALFATE TABLET [CARDINAL HEALTH]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUCRALFATE TABLET [MYLAN INSTITUTIONAL INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUCRALFATE TABLET [CARDINAL HEALTH]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUCRALFATE TABLET [MYLAN INSTITUTIONAL INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSUCRALFATE TABLET [CARDINAL HEALTH]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSUCRALFATE TABLET [MYLAN INSTITUTIONAL INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51079-753SUCRALFATE TABLET [MYLAN INSTITUTIONAL INC.]9Current NDC, Legacy NDC, 2 package rows20250109_989ca8a8-3ad6-4ee4-aa9c-eed731828753.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314234sucralfate 1 GM Oral TabletPSN989ca8a8-3ad6-4ee4-aa9c-eed73182875310
314234sucralfate 1000 MG Oral TabletSCD989ca8a8-3ad6-4ee4-aa9c-eed73182875310
314234sucralfate 1 GM Oral TabletSY989ca8a8-3ad6-4ee4-aa9c-eed73182875310
314234sucralfate 1 GM Oral TabletPSN444a743a-4843-4b33-bad5-3dfc1fb2d0049
314234sucralfate 1000 MG Oral TabletSCD444a743a-4843-4b33-bad5-3dfc1fb2d0049
314234sucralfate 1 GM Oral TabletSY444a743a-4843-4b33-bad5-3dfc1fb2d0049

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-753-01510790753011 in 1 BLISTER PACKHistorical
51079-753-2051079075320100 BLISTER PACK in 1 CARTON (51079-753-20) / 1 TABLET in 1 BLISTER PACK (51079-753-01) 100 blister pack2013-09-240000-00-00NoNoCurrent