FDA.reportPublic FDA data

Sucralfate

Product NDC
0904-7470
11-digit product format
009047470
Labeler code
0904
Product ID
0904-7470_91b1db83-0f5e-4433-9104-6a2c315d13c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SUCRALFATE Oral Suspension
Dosage form
SUSPENSION
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA211884
Marketing category
ANDA
Marketing start
2024-06-26
Substance
SUCRALFATE
Active strength
1 g/10mL
Pharmacologic classes
Aluminum Complex [EPC], Organometallic Compounds [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sucralfate
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7470-01Sucralfate30 in 1 CASESUSPENSION303
0904-7470-18Sucralfate40 in 1 CARTRIDGESUSPENSION403
0904-7470-56Sucralfate20 in 1 CASESUSPENSION203
0904-7470-66Sucralfate10 mL in 1 CUP, UNIT-DOSESUSPENSION103
0904-7470-72Sucralfate100 in 1 CASESUSPENSION1003
0904-7470-95Sucralfate50 in 1 CASESUSPENSION503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7470-01ML - Milliliter0904-7470555b692a-70ab-4de3-b0f0-5732cc583b1b12024-07-12
0904-7470-18ML - Milliliter0904-7470169e5a87-cc05-48f5-80d0-1cc0a359f12b12024-10-04
0904-7470-56ML - Milliliter0904-7470923e8a6d-96ea-47c4-af96-896a9015d6c412024-07-12
0904-7470-66ML - Milliliter0904-7470af1337a2-99c9-4f11-bd6e-61d387c25fa312024-07-12
0904-7470-72ML - Milliliter0904-74706d89e830-4eed-4b05-97b2-fc8bdea21c7512024-07-12
0904-7470-95ML - Milliliter0904-7470bb550e52-7bc6-4692-8a7d-0ce4ae9507da12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7470SUCRALFATE (SUCRALFATE ORAL SUSPENSION) SUSPENSION [MAJOR PHARMACEUTICALS]2Current NDC, 6 package rows20250504_98a8fedd-fa06-416a-8a85-b899631978f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313123sucralfate 1 GM in 10 mL Oral SuspensionPSN98a8fedd-fa06-416a-8a85-b899631978f93
313123sucralfate 100 MG/ML Oral SuspensionSCD98a8fedd-fa06-416a-8a85-b899631978f93
313123sucralfate 1 GM per 10 ML Oral SuspensionSY98a8fedd-fa06-416a-8a85-b899631978f93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7470-010090474700130 CUP, UNIT-DOSE in 1 CASE (0904-7470-01) / 10 mL in 1 CUP, UNIT-DOSE (0904-7470-66) 2024-06-26NoNoHistorical
0904-7470-180090474701840 CUP, UNIT-DOSE in 1 CARTRIDGE (0904-7470-18) / 10 mL in 1 CUP, UNIT-DOSE (0904-7470-66) 2024-06-26NoNoHistorical
0904-7470-560090474705620 CUP, UNIT-DOSE in 1 CASE (0904-7470-56) / 10 mL in 1 CUP, UNIT-DOSE (0904-7470-66) 2024-06-26NoNoHistorical
0904-7470-660090474706610 mL in 1 CUP, UNIT-DOSE (0904-7470-66) 10 ml2024-06-26NoNoHistorical
0904-7470-7200904747072100 CUP, UNIT-DOSE in 1 CASE (0904-7470-72) / 10 mL in 1 CUP, UNIT-DOSE (0904-7470-66) 2024-06-26NoNoHistorical
0904-7470-950090474709550 CUP, UNIT-DOSE in 1 CASE (0904-7470-95) / 10 mL in 1 CUP, UNIT-DOSE (0904-7470-66) 2024-06-262026-10-31NoNoHistorical