FDA.reportPublic FDA data

NDC 80425-0091-01 - 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
80425-0091
Requested NDC
80425-0091-01
Package NDCs from labels
80425-0091-1, 80425-0091-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sucralfate - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0091-1Sucralfate30 in 1 BOTTLETABLET305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0091SUCRALFATE TABLET [ADVANCED RX OF TENNESSEE, LLC]5Current NDC, Legacy NDC, 1 package rows20250101_b39f22c8-f224-451a-e053-2995a90aaad7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0091-1EA - Each80425-0091187cb544-ae9f-4e7a-b21a-eb980ad159f412023-06-06

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 2 of 4 · 67 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SucralfateSUCRALFATENorthwind Health Company, LLCf3095db3-fd02-873c-e053-2a95a90a5b1f2026-01-01Adverse reactionsExact identifier
rxcui: 314234
unii: XX73205DH5
SucralfateSUCRALFATE ORALTruPharma, LLC7d441128-45d2-4bf2-817b-665784992e902025-12-29Warnings, Adverse reactionsExact identifier
unii: XX73205DH5
SucralfateSUCRALFATENorthwind Health Company, LLC464bf611-4dbb-4707-b9dd-39ca178ed4bf2025-12-26Adverse reactionsExact identifier
application number: ANDA070848
rxcui: 314234
unii: XX73205DH5
SucralfateSUCRALFATERedpharm Drug3251e156-4c52-63b3-e063-6294a90a9a952025-12-18Adverse reactionsExact identifier
rxcui: 314234
unii: XX73205DH5
SucralfateSUCRALFATE ORALAvKAREc019bf24-8273-8d2f-e053-2a95a90aec982025-12-03Warnings, Adverse reactionsExact identifier
unii: XX73205DH5
SucralfateSUCRALFATE ORALAvPAKe78ef7d4-faa7-aebf-e053-2995a90a6f842025-12-03Warnings, Adverse reactionsExact identifier
unii: XX73205DH5
SucralfateSUCRALFATETorrent Pharmaceuticals Limiteddc361b46-fda4-4b0b-9950-e8885ba5b0842025-08-21Warnings, Adverse reactionsExact identifier
unii: XX73205DH5
SucralfateSUCRALFATEMylan Institutional Inc.989ca8a8-3ad6-4ee4-aa9c-eed7318287532025-07-22Adverse reactionsExact identifier
application number: ANDA070848
rxcui: 314234
unii: XX73205DH5
SucralfateSUCRALFATEKesin Pharma Corporation36d940f2-207b-68c5-e063-6294a90a6b4a2025-07-01Warnings, Adverse reactionsExact identifier
unii: XX73205DH5
SucralfateSUCRALFATENCS HealthCare of KY, LLC dba Vangard Labsd67dcaad-56c1-4e77-a0c8-6559708084142025-06-13Adverse reactionsExact identifier
application number: ANDA070848
rxcui: 314234
unii: XX73205DH5
SucralfateSUCRALFATEBryant Ranch Prepacka73010fb-960c-4567-8ab1-6d902fee2c142025-06-02Adverse reactionsExact identifier
rxcui: 314234
unii: XX73205DH5
SucralfateSUCRALFATEATLANTIC BIOLOGICALS CORP.e5073597-ac51-4e7c-a9dc-7695773a01f12025-05-27Warnings, Adverse reactionsExact identifier
unii: XX73205DH5
SucralfateSUCRALFATERichmond Pharmaceuticals, Inc.7ac10c3f-9d50-4702-900c-41075ac6f8962025-05-23Warnings, Adverse reactionsExact identifier
unii: XX73205DH5
sucralfateSUCRALFATEBryant Ranch Prepackabc44549-ac41-4aef-9b15-2ba536e1555f2025-05-09Warnings, Adverse reactionsExact identifier
unii: XX73205DH5
SucralfateSUCRALFATENuCare Pharmaceuticals, Inc.31a7dcd0-e677-249a-e063-6294a90a75f62025-03-19Adverse reactionsExact identifier
rxcui: 314234
unii: XX73205DH5
SucralfateSUCRALFATECoupler LLC2d586736-73ae-9af0-e063-6294a90ad8752025-02-04Adverse reactionsExact identifier
rxcui: 314234
unii: XX73205DH5
SucralfateSUCRALFATE ORALPrecision Dose, Inc.0dc592e9-541c-4fac-8ab5-829d43521c012025-01-28Warnings, Adverse reactionsExact identifier
unii: XX73205DH5
SucralfateSUCRALFATEDirect_Rxf5f0fecb-949c-3998-e053-2a95a90aac8c2025-01-22Adverse reactionsExact identifier
rxcui: 314234
unii: XX73205DH5
SUCRALFATESUCRALFATEDIRECT RXc50b5044-31ed-672a-e053-2995a90a49fc2025-01-20Adverse reactionsExact identifier
application number: ANDA070848
rxcui: 314234
unii: XX73205DH5
SucralfateSUCRALFATENuCare Pharmaceuticals,Inc.0206d7fa-a1d5-35d9-e063-6294a90a5eb32025-01-03Adverse reactionsExact identifier
rxcui: 314234
unii: XX73205DH5

Reported adverse events (FAERS/openFDA)#

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