FDA.reportPublic FDA data

NDC 68788-8316-03 - Sucralfate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68788-8316
Requested NDC
68788-8316-03
Package NDCs from labels
68788-8316-3, 68788-8316-1, 68788-8316-03
Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2026-09-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sucralfate TabletsPreferred Pharmaceuticals Inc.2026-09-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8316-1Sucralfate100 in 1 BOTTLETABLET1004
68788-8316-3Sucralfate30 in 1 BOTTLETABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8316SUCRALFATE TABLET [PREFERRED PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 2 package rows20240816_536b8c00-13ab-4397-a754-63a1c92bf883.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8316-1EA - Each68788-83164572bc17-393c-4077-ba89-a9ba0990516612023-02-06
68788-8316-3EA - Each68788-83165e980374-bd15-41b5-8139-3f1c4de9cc6112023-02-06

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 4 · 79 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SucralfateSUCRALFATEPreferred Pharmaceuticals Inc.536b8c00-13ab-4397-a754-63a1c92bf8832026-09-02Adverse reactionsExact identifier
application number: NDA018333
ndc (package): 68788-8316-3
ndc (package): 68788-8316-1
ndc (product): 68788-8316
ndc11 (package): 68788831603
rxcui: 314234
spl id: c188e20b-1bd3-40e7-996b-7291464b1301
spl set id: 536b8c00-13ab-4397-a754-63a1c92bf883
unii: XX73205DH5
SucralfateSUCRALFATEVistaPharm, LLCcbfbe146-5d42-4a55-9050-df2b5581487a2026-09-02Warnings, Adverse reactionsExact identifier
unii: XX73205DH5
SucralfateSUCRALFATEPreferred Pharmaceuticals Inc.5ec71444-cc55-47bd-8abc-b3cfc3b47d8e2026-09-01Adverse reactionsExact identifier
rxcui: 314234
unii: XX73205DH5
SucralfateSUCRALFATEChartwell RX, LLC37aee721-b9c7-4e6b-a1a1-e826d8541d6b2026-08-27Warnings, Adverse reactionsExact identifier
unii: XX73205DH5
SucralfateSUCRALFATEZydus Lifesciences Limited882b7596-f62c-4be2-8f67-e64310718baa2026-08-08Adverse reactionsExact identifier
rxcui: 314234
unii: XX73205DH5
SucralfateSUCRALFATEViona Pharmaceuticals Incc708201b-2618-4470-a3ff-8ecf04d6b3a02026-08-08Adverse reactionsExact identifier
rxcui: 314234
unii: XX73205DH5
SucralfateSUCRALFATECardinal Health 107, LLC444a743a-4843-4b33-bad5-3dfc1fb2d0042026-07-29Adverse reactionsExact identifier
rxcui: 314234
unii: XX73205DH5
SucralfateSUCRALFATESafecor Health, LLC526f6ebc-557c-4c53-8118-1907baa0820a2026-07-16Warnings, Adverse reactionsExact identifier
unii: XX73205DH5
SucralfateSUCRALFATECardinal Health 107, LLC1eb38f64-4d5a-46e6-a030-057beece5e442026-07-10Adverse reactionsExact identifier
rxcui: 314234
unii: XX73205DH5
SucralfateSUCRALFATEChartwell RX, LLC30c0965a-02a0-46b5-aa09-3f5fb5047b222026-07-06Adverse reactionsExact identifier
rxcui: 314234
unii: XX73205DH5
SucralfateSUCRALFATENCS HealthCare of KY, LLC dba Vangard Labs3b0259fa-806f-44c1-8deb-c11dbd84582d2026-06-24Adverse reactionsExact identifier
rxcui: 314234
unii: XX73205DH5
SucralfateSUCRALFATEASCLEMED USA INC.cd25eb96-29ea-48b2-bdee-c2ea98f216b82026-05-18Adverse reactionsExact identifier
rxcui: 314234
unii: XX73205DH5
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
SucralfateSUCRALFATESafecor Health LLC1a6d96f2-fe1f-4aaf-8520-616973c224aa2026-04-07Adverse reactionsExact identifier
rxcui: 314234
unii: XX73205DH5
SucralfateSUCRALFATECardinal Health 107, LLC92c8672a-c6b8-4ec8-a815-c30bdd960ac72026-03-30Warnings, Adverse reactionsExact identifier
unii: XX73205DH5
SucralfateSUCRALFATEPAI Holdings, LLC dba PAI Pharma113a068a-2ce9-421c-8b89-87ce30e192252026-03-11Warnings, Adverse reactionsExact identifier
unii: XX73205DH5
sucralfateSUCRALFATEStrides Pharma Science Limited8e25bff2-769e-4bd4-a6de-895c58b840d22026-03-10Warnings, Adverse reactionsExact identifier
unii: XX73205DH5
SucralfateSUCRALFATE ORAL SUSPENSIONMajor Pharmaceuticals98a8fedd-fa06-416a-8a85-b899631978f92026-02-11Warnings, Adverse reactionsExact identifier
unii: XX73205DH5
SucralfateSUCRALFATEPreferred Pharmaceuticals Inca434bf8f-cc60-4d84-a9a4-61c3ff6b700e2026-01-21Adverse reactionsExact identifier
rxcui: 314234
unii: XX73205DH5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.