FDA.reportPublic FDA data

Sucralfate

Product NDC
82804-063
11-digit product format
828040063
Labeler code
82804
Product ID
82804-063_a42c5f3d-85f1-485b-91e6-58c25b3ddc71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sucralfate
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA070848
Marketing category
ANDA
Marketing start
1996-11-11
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
82804-063-30Sucralfate30 in 1 BOTTLETABLET301
82804-063-60Sucralfate60 in 1 BOTTLETABLET601
82804-063-90Sucralfate90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-063-30EA - Each82804-063e0b59184-8242-4dc4-90d8-3d1306b2b90b12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-063SUCRALFATE TABLET [PROFICIENT RX LP]1Current NDC, 3 package rows20240201_a42c5f3d-85f1-485b-91e6-58c25b3ddc71.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314234sucralfate 1 GM Oral TabletPSNa42c5f3d-85f1-485b-91e6-58c25b3ddc711
314234sucralfate 1000 MG Oral TabletSCDa42c5f3d-85f1-485b-91e6-58c25b3ddc711
314234sucralfate 1 GM Oral TabletSYa42c5f3d-85f1-485b-91e6-58c25b3ddc711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-063-308280400633030 TABLET in 1 BOTTLE (82804-063-30) 30 tablet2024-01-30NoNoCurrent
82804-063-608280400636060 TABLET in 1 BOTTLE (82804-063-60) 60 tablet2024-01-30NoNoCurrent
82804-063-908280400639090 TABLET in 1 BOTTLE (82804-063-90) 90 tablet2024-01-30NoNoCurrent