Sucralfate

Product NDC
50742-386
11-digit product format
507420386
Labeler code
50742
Product ID
50742-386_03497f8d-e649-40bf-b5c9-2df985b0fab4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sucralfate
Dosage form
SUSPENSION
Route
ORAL
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA216726
Marketing category
ANDA
Marketing start
2024-11-21
Marketing end
2026-07-31
Substance
SUCRALFATE
Active strength
1 g/10mL
Pharmacologic classes
Aluminum Complex [EPC], Organometallic Compounds [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sucralfate

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SUCRALFATE1 g/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXX73205DH5
Rxcui313123

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
01e96ee1-fe82-0132-025c-ec1559bf8b6eProduct name520260127
f9fa5fa8-e047-2182-3e2c-c4a9ec6531cdProduct name320240508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50742-386-42Sucralfate420 mL in 1 BOTTLESUSPENSION4206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-386-42ML - Milliliter50742-38687ff8032-17bc-47b0-b5ce-11770e9534c912025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-386SUCRALFATE SUSPENSION [INGENUS PHARMACEUTICALS, LLC]5Current NDC, 1 package rows20241123_1921b3fc-f55c-e503-e063-6394a90a7da9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313123sucralfate 1 GM in 10 mL Oral SuspensionPSN1921b3fc-f55c-e503-e063-6394a90a7da96
313123sucralfate 100 MG/ML Oral SuspensionSCD1921b3fc-f55c-e503-e063-6394a90a7da96
313123sucralfate 1 GM per 10 ML Oral SuspensionSY1921b3fc-f55c-e503-e063-6394a90a7da96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50742-386-4250742038642420 mL in 1 BOTTLE (50742-386-42) 420 ml2024-11-212026-07-31NoNoHistorical