FDA.reportPublic FDA data

Carafate

Product NDC
58914-170
11-digit product format
589140170
Labeler code
58914
Product ID
58914-170_cb835be9-f4ba-47c4-b1db-d2f731371432
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sucralfate
Dosage form
SUSPENSION
Route
ORAL
Labeler
Allergan, Inc.
Application
NDA019183
Marketing category
NDA
Marketing start
1993-12-16
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
Carafate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SUCRALFATE1 g/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXX73205DH5
Rxcui208094, 313123

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
58914-170-14Carafate420 mL in 1 BOTTLESUSPENSION42020
58914-170-60Carafate6 in 1 BOXSUSPENSION620
58914-170-60Carafate10 mL in 1 CUP, UNIT-DOSESUSPENSION1020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58914-170-14ML - Milliliter58914-1709dd6aa5a-bd0f-40d0-b804-c40cc092ff6312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SucralfateACTIVE INGREDIENTXX73205DH5CARAFATE (SUCRALFATE) SUSPENSION [APTALIS PHARMA INC.]8
SucralfateACTIVE MOIETYXX73205DH5CARAFATE (SUCRALFATE) SUSPENSION [APTALIS PHARMA INC.]8
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACARAFATE (SUCRALFATE) SUSPENSION [APTALIS PHARMA INC.]8
GlycerinINACTIVE INGREDIENTPDC6A3C0OXCARAFATE (SUCRALFATE) SUSPENSION [APTALIS PHARMA INC.]8
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TCARAFATE (SUCRALFATE) SUSPENSION [APTALIS PHARMA INC.]8
SorbitolINACTIVE INGREDIENT506T60A25RCARAFATE (SUCRALFATE) SUSPENSION [APTALIS PHARMA INC.]8
WaterINACTIVE INGREDIENT059QF0KO0RCARAFATE (SUCRALFATE) SUSPENSION [APTALIS PHARMA INC.]8
SucralfateACTIVE INGREDIENTXX73205DH5CARAFATE (SUCRALFATE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
SucralfateACTIVE MOIETYXX73205DH5CARAFATE (SUCRALFATE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACARAFATE (SUCRALFATE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
GlycerinINACTIVE INGREDIENTPDC6A3C0OXCARAFATE (SUCRALFATE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TCARAFATE (SUCRALFATE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
SorbitolINACTIVE INGREDIENT506T60A25RCARAFATE (SUCRALFATE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RCARAFATE (SUCRALFATE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
SUCRALFATEACTIVE INGREDIENTXX73205DH5SUCRALFATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
SUCRALFATEACTIVE MOIETYXX73205DH5SUCRALFATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUCRALFATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASUCRALFATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSUCRALFATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SUCRALFATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RSUCRALFATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSUCRALFATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58914-170CARAFATE (SUCRALFATE) SUSPENSION [ALLERGAN, INC.]20Current NDC, Legacy NDC, 3 package rows20240207_0fb67b1c-b4c0-46f2-8a81-df1510e006aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
208094Carafate 1 GM in 10 mL Oral SuspensionPSN0fb67b1c-b4c0-46f2-8a81-df1510e006aa20
313123sucralfate 1 GM in 10 mL Oral SuspensionPSN0fb67b1c-b4c0-46f2-8a81-df1510e006aa20
208094sucralfate 100 MG/ML Oral Suspension [Carafate]SBD0fb67b1c-b4c0-46f2-8a81-df1510e006aa20
313123sucralfate 100 MG/ML Oral SuspensionSCD0fb67b1c-b4c0-46f2-8a81-df1510e006aa20
208094Carafate 1 GM per 10 ML Oral SuspensionSY0fb67b1c-b4c0-46f2-8a81-df1510e006aa20
208094Carafate 100 MG/ML Oral SuspensionSY0fb67b1c-b4c0-46f2-8a81-df1510e006aa20
313123sucralfate 1 GM per 10 ML Oral SuspensionSY0fb67b1c-b4c0-46f2-8a81-df1510e006aa20
208094Carafate 1 GM in 10 mL Oral SuspensionPSN64ae3d08-5651-463e-a255-9004100433e76
313123sucralfate 1 GM in 10 mL Oral SuspensionPSN64ae3d08-5651-463e-a255-9004100433e76
208094sucralfate 100 MG/ML Oral Suspension [Carafate]SBD64ae3d08-5651-463e-a255-9004100433e76
313123sucralfate 100 MG/ML Oral SuspensionSCD64ae3d08-5651-463e-a255-9004100433e76
208094Carafate 1 GM per 10 ML Oral SuspensionSY64ae3d08-5651-463e-a255-9004100433e76
208094Carafate 100 MG/ML Oral SuspensionSY64ae3d08-5651-463e-a255-9004100433e76
313123sucralfate 1 GM per 10 ML Oral SuspensionSY64ae3d08-5651-463e-a255-9004100433e76
208094Carafate 1 GM in 10 mL Oral SuspensionPSN0bd18d2a-07b3-4155-b08a-bdd0cfd0bd2e2
313123sucralfate 1 GM in 10 mL Oral SuspensionPSN0bd18d2a-07b3-4155-b08a-bdd0cfd0bd2e2
208094sucralfate 100 MG/ML Oral Suspension [Carafate]SBD0bd18d2a-07b3-4155-b08a-bdd0cfd0bd2e2
313123sucralfate 100 MG/ML Oral SuspensionSCD0bd18d2a-07b3-4155-b08a-bdd0cfd0bd2e2
208094Carafate 1 GM per 10 ML Oral SuspensionSY0bd18d2a-07b3-4155-b08a-bdd0cfd0bd2e2
208094Carafate 100 MG/ML Oral SuspensionSY0bd18d2a-07b3-4155-b08a-bdd0cfd0bd2e2
313123sucralfate 1 GM per 10 ML Oral SuspensionSY0bd18d2a-07b3-4155-b08a-bdd0cfd0bd2e2
313123sucralfate 1 GM in 10 mL Oral SuspensionPSN187ce680-e3de-45cb-98f3-96e069804c621
313123sucralfate 100 MG/ML Oral SuspensionSCD187ce680-e3de-45cb-98f3-96e069804c621
313123sucralfate 1 GM per 10 ML Oral SuspensionSY187ce680-e3de-45cb-98f3-96e069804c621

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58914-170-1458914017014420 mL in 1 BOTTLE (58914-170-14) 420 ml1993-12-160000-00-00NoNoCurrent
58914-170-60589140170606 CUP, UNIT-DOSE in 1 BOX (58914-170-60) / 10 mL in 1 CUP, UNIT-DOSE1993-12-160000-00-00YesNoCurrent