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 3 of 4 · 67 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SucralfateSUCRALFATEAdvanced Rx of Tennessee, LLCb39f22c8-f224-451a-e053-2995a90aaad72024-12-31Adverse reactionsExact identifier
application number: ANDA070848
ndc (package): 80425-0091-1
ndc (product): 80425-0091
ndc11 (package): 80425009101
rxcui: 314234
spl id: 2a994dc6-72f5-0559-e063-6394a90a0ecf
spl set id: b39f22c8-f224-451a-e053-2995a90aaad7
unii: XX73205DH5
SucralfateSUCRALFATEAdvanced Rx Pharmacy of Tennessee, LLCd3c41720-7e1a-08c1-e053-2a95a90aba032024-12-31Adverse reactionsExact identifier
rxcui: 314234
unii: XX73205DH5
SucralfateSUCRALFATEAdvanced Rx Pharmacy of Tennessee, LLCf15fbb45-4406-0d32-e053-2995a90a40c52024-12-31Adverse reactionsExact identifier
rxcui: 314234
unii: XX73205DH5
SucralfateSUCRALFATECosette Pharmaceuticals, Inc.3054ce94-78a2-4da4-8b14-95311b412ab22024-11-25Warnings, Adverse reactionsExact identifier
unii: XX73205DH5
SucralfateSUCRALFATE ORALAmneal Pharmaceuticals LLC4350b771-76a9-4e00-93f0-a18c71288f832024-10-30Warnings, Adverse reactionsExact identifier
unii: XX73205DH5
SucralfateSUCRALFATEBryant Ranch Prepacka068e818-8da3-4f0d-88e0-acc88e76f3aa2024-08-22Adverse reactionsExact identifier
rxcui: 314234
unii: XX73205DH5
SucralfateSUCRALFATENuCare Pharmaceuticals,Inc.a40e43d4-9240-34ad-e053-2995a90a98e12024-07-15Adverse reactionsExact identifier
application number: ANDA070848
rxcui: 314234
unii: XX73205DH5
CarafateSUCRALFATEAllergan, Inc.c87c6b50-6977-4fa7-ae98-40c0753f7aee2024-05-21Adverse reactionsExact identifier
rxcui: 314234
unii: XX73205DH5
SucralfateSUCRALFATEProficient Rx LP51459cdb-a04a-49c2-8ee4-8f234f5224762024-05-01Adverse reactionsExact identifier
rxcui: 314234
unii: XX73205DH5
SucralfateSUCRALFATEAdvanced Rx Pharmacy of Tennessee, LLC138f0929-caad-56c6-e063-6294a90a55ef2024-03-13Adverse reactionsExact identifier
rxcui: 314234
unii: XX73205DH5
SucralfateSUCRALFATEAmneal Pharmaceuticals NY LLCb2e07ac7-4a8a-4b68-bb65-167d1aa868832024-03-01Adverse reactionsExact identifier
rxcui: 314234
unii: XX73205DH5
SucralfateSUCRALFATEBryant Ranch Prepack28d7d257-8545-4b9f-8412-8ba1445024002024-02-23Adverse reactionsExact identifier
rxcui: 314234
unii: XX73205DH5
SucralfateSUCRALFATEPacific Pharma, Inc.7407c58e-766f-4e93-a1bb-c77892ae01742024-02-10Warnings, Adverse reactionsExact identifier
unii: XX73205DH5
SucralfateSUCRALFATEBryant Ranch Prepack7b05323d-4695-41d7-8236-1e7b4e8f2a1e2024-01-11Adverse reactionsExact identifier
rxcui: 314234
unii: XX73205DH5
SucralfateSUCRALFATEBryant Ranch Prepack25ae2ebc-a7e0-4fc9-a8d1-07f7dd7138e52024-01-11Adverse reactionsExact identifier
rxcui: 314234
unii: XX73205DH5
SucralfateSUCRALFATEProficient Rx LPa42c5f3d-85f1-485b-91e6-58c25b3ddc712024-01-01Adverse reactionsExact identifier
application number: ANDA070848
rxcui: 314234
unii: XX73205DH5
SucralfateSUCRALFATEAmneal Pharmaceuticals NY LLCa4f722e7-2885-4f27-8358-9c662439600a2023-12-30Adverse reactionsExact identifier
rxcui: 314234
unii: XX73205DH5
SucralfateSUCRALFATEAmerican Health Packaginge4761fb2-6a1a-44de-9d27-f6addabc24c82023-08-10Warnings, Adverse reactionsExact identifier
unii: XX73205DH5
SucralfateSUCRALFATEA-S Medication Solutions793d033d-d341-4910-8dda-d43d8fd03a4d2023-06-29Adverse reactionsExact identifier
rxcui: 314234
unii: XX73205DH5
CarafateSUCRALFATEAllergan, Inc.0fb67b1c-b4c0-46f2-8a81-df1510e006aa2023-06-08Warnings, Adverse reactionsExact identifier
unii: XX73205DH5

Reported adverse events (FAERS/openFDA)#

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