FDA.reportPublic FDA data

Sucralfate

Product NDC
60687-738
11-digit product format
606870738
Labeler code
60687
Product ID
60687-738_02935a29-75bc-0f18-e063-6294a90a1405
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sucralfate
Dosage form
SUSPENSION
Route
ORAL
Labeler
American Health Packaging
Application
ANDA211884
Marketing category
ANDA
Marketing start
2023-08-01
Substance
SUCRALFATE
Active strength
1 g/10mL
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/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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-738-08Sucralfate3 in 1 CASESUSPENSION33
60687-738-23Sucralfate4 in 1 CASESUSPENSION43
60687-738-42Sucralfate10 mL in 1 CUP, UNIT-DOSESUSPENSION103
60687-738-48Sucralfate10 in 1 TRAYSUSPENSION103
60687-738-56Sucralfate10 in 1 CASESUSPENSION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-738-08ML - Milliliter60687-73803711a6d-7214-486c-8afb-254df576fad812023-06-06
60687-738-23ML - Milliliter60687-738628c5853-6fb0-472a-b0c2-d0ccf9e9212e12023-06-06
60687-738-42ML - Milliliter60687-7388cb7a7b4-35cd-480c-a2aa-6d8e1770fb2c12023-06-06
60687-738-56ML - Milliliter60687-738622fa4fd-cbf2-4e76-8a31-ee735a9fb98912023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-738SUCRALFATE SUSPENSION [AMERICAN HEALTH PACKAGING]3Current NDC, 5 package rows20230811_e4761fb2-6a1a-44de-9d27-f6addabc24c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313123sucralfate 1 GM in 10 mL Oral SuspensionPSNe4761fb2-6a1a-44de-9d27-f6addabc24c83
313123sucralfate 100 MG/ML Oral SuspensionSCDe4761fb2-6a1a-44de-9d27-f6addabc24c83
313123sucralfate 1 GM per 10 ML Oral SuspensionSYe4761fb2-6a1a-44de-9d27-f6addabc24c83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-738-08606870738083 TRAY in 1 CASE (60687-738-08) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-738-48) / 10 mL in 1 CUP, UNIT-DOSE (60687-738-42) 3 tray2023-08-01NoNoHistorical
60687-738-23606870738234 TRAY in 1 CASE (60687-738-23) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-738-48) / 10 mL in 1 CUP, UNIT-DOSE (60687-738-42) 4 tray2023-08-01NoNoHistorical
60687-738-426068707384210 mL in 1 CUP, UNIT-DOSE10 mlHistorical
60687-738-486068707384810 in 1 TRAYHistorical
60687-738-566068707385610 TRAY in 1 CASE (60687-738-56) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-738-48) / 10 mL in 1 CUP, UNIT-DOSE (60687-738-42) 10 tray2023-08-01NoNoHistorical