FDA.reportPublic FDA data

NDC 67046-1469-03 - 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
67046-1469
Requested NDC
67046-1469-03
Package NDCs from labels
67046-1469-3, 67046-1469-03
Manufacturer
Coupler LLC | Zydus Lifesciences Limited
Effective date
2025-02-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sucralfate - Coupler LLC | Zydus Lifesciences LimitedCoupler LLC | Zydus Lifesciences Limited2025-02-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-1469-3Sucralfate30 in 1 BLISTER PACKTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-1469SUCRALFATE TABLET [COUPLER LLC]1Current NDC, 1 package rows20250206_2d586736-73ae-9af0-e063-6294a90ad875.zip

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 · 76 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SucralfateSUCRALFATEPreferred Pharmaceuticals Inc.536b8c00-13ab-4397-a754-63a1c92bf8832026-09-02Adverse reactionsExact identifier
rxcui: 314234
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
application number: ANDA215705
rxcui: 314234
unii: XX73205DH5
SucralfateSUCRALFATEViona Pharmaceuticals Incc708201b-2618-4470-a3ff-8ecf04d6b3a02026-08-08Adverse reactionsExact identifier
application number: ANDA215705
ndc (product): 72578-081
rxcui: 314234
spl id: dd615804-6bb1-4c0a-bafb-7f6c27c55df4
spl set id: c708201b-2618-4470-a3ff-8ecf04d6b3a0
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
application number: ANDA215705
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
application number: ANDA215705
rxcui: 314234
unii: XX73205DH5

Reported adverse events (FAERS/openFDA)#

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