FDA.reportPublic FDA data

NDC 80425-0174-01 - Lansoprazole DR

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
80425-0174
Requested NDC
80425-0174-01
Package NDCs from labels
80425-0174-1, 80425-0174-01
Manufacturer
Advanced Rx Pharmacy 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
Lansoprazole DR - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0174-1LansoprazoleDR30 in 1 BOTTLECAPSULE, DELAYED RELEASE306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0174LANSOPRAZOLE DR (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]6Current NDC, Legacy NDC, 1 package rows20250101_ce1a4f32-da65-29d3-e053-2995a90a42ee.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0174-1EA - Each80425-0174bd3ee179-b80f-471f-9d2e-ac583382ce1a12023-06-06

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 6 · 104 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
lansoprazoleLANSOPRAZOLEBryant Ranch Prepackbd278054-875e-4877-991c-cbdf3975f93e2025-03-31WarningsExact identifier
rxcui: 596843
unii: 0K5C5T2QPG
lansoprazoleLANSOPRAZOLEPadagis Israel Pharmaceuticals Ltd17f41872-f3d1-4b02-b6ce-0e731139495a2025-03-26WarningsExact identifier
rxcui: 596843
unii: 0K5C5T2QPG
equate lansoprazoleLANSOPRAZOLEWALMART INC.3a7aadbd-0a70-444f-95e1-cbde827818922025-03-14WarningsExact identifier
rxcui: 596843
unii: 0K5C5T2QPG
dg health lansoprazoleLANSOPRAZOLEDolgencorp Ince6e3bcee-636f-4361-85f8-9ba5a0f3c7412025-03-04WarningsExact identifier
rxcui: 596843
unii: 0K5C5T2QPG
LansoprazoleLANSOPRAZOLEQuallent Pharmaceuticals Health LLCcc006372-32d3-4539-921a-6bc9ec496b282025-02-28Warnings, Adverse reactionsExact identifier
rxcui: 311277
unii: 0K5C5T2QPG
Lansoprazole, Amoxicillin, ClarithromycinLANSOPRAZOLE, AMOXICILLIN, CLARITHROMYCINRising Pharma Holdings, Inc.40adc1d3-7ce7-4698-aa7f-b5dbaaecec002025-02-19Warnings, Adverse reactionsExact identifier
rxcui: 311277
equaline lansoprazoleLANSOPRAZOLEUnited Natural Foods, Inc. dba UNFIbf8c337c-4a45-46e6-ae8e-46df80ca66e32025-02-13WarningsExact identifier
rxcui: 596843
unii: 0K5C5T2QPG
lansoprazoleLANSOPRAZOLEPublix Super Markets Inc86a99ee3-0e98-46e8-8473-f8c812044a2f2025-02-13WarningsExact identifier
rxcui: 596843
unii: 0K5C5T2QPG
topcare lansoprazoleLANSOPRAZOLETopco Associates LLC73aec019-5337-48a4-b95c-993fff9cfc2a2025-02-13WarningsExact identifier
rxcui: 596843
unii: 0K5C5T2QPG
Kirkland Signature LansoprazoleLANSOPRAZOLECostco Wholesale Company326aabe6-c4ac-4bca-949f-38015dcbaf4e2025-02-12WarningsExact identifier
rxcui: 596843
unii: 0K5C5T2QPG
lansoprazoleLANSOPRAZOLEKroger Company4c0684b5-5c18-4ed5-8185-8b5d51dce3a02025-02-08WarningsExact identifier
unii: 0K5C5T2QPG
LansoprazoleLANSOPRAZOLECVS Pharmacy992a8f95-475c-4e57-90cc-9839c86784272025-02-08WarningsExact identifier
unii: 0K5C5T2QPG
topcare LansoprazoleLANSOPRAZOLETopco Associates LLCec5d6d5c-11e7-4932-a48f-fb72218ceccd2025-02-08WarningsExact identifier
unii: 0K5C5T2QPG
basic care lansoprazoleLANSOPRAZOLEAmazon.com Services LLC6b57eb00-74fd-435f-bd08-086c9f8ac62c2025-02-05WarningsExact identifier
rxcui: 596843
unii: 0K5C5T2QPG
Good Sense LansoprazoleLANSOPRAZOLEL. Perrigo Companyd86585b7-e146-4f04-9016-412b16e06f552025-01-29WarningsExact identifier
unii: 0K5C5T2QPG
basic care lansoprazoleLANSOPRAZOLEAmazon.com Services LLCf39feec2-54fb-47d4-9b45-08f75e92117e2025-01-24WarningsExact identifier
unii: 0K5C5T2QPG
LansoprazoleLANSOPRAZOLEAmerican Health Packagingdee80a19-e514-41e6-9153-c959699d97b12025-01-07Warnings, Adverse reactionsExact identifier
rxcui: 596843
rxcui: 311277
unii: 0K5C5T2QPG
LansoprazoleLANSOPRAZOLENuCare Pharmaceuticals,Inc.1c364fc5-eb43-b12f-e063-6294a90a43192025-01-02Warnings, Adverse reactionsExact identifier
application number: ANDA205868
rxcui: 596843
unii: 0K5C5T2QPG
LansoprazoleLANSOPRAZOLENuCare Pharmaceuticals,Inc.1bbb8f3a-80bf-b881-e063-6294a90ab4f22025-01-02Warnings, Adverse reactionsExact identifier
rxcui: 596843
unii: 0K5C5T2QPG
Lansoprazole DRLANSOPRAZOLEAdvanced Rx Pharmacy of Tennessee, LLCce1a4f32-da65-29d3-e053-2995a90a42ee2024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA205868
ndc (package): 80425-0174-1
ndc (product): 80425-0174
ndc11 (package): 80425017401
rxcui: 311277
spl id: 2a99b1dd-bed3-79f9-e063-6394a90a35f3
spl set id: ce1a4f32-da65-29d3-e053-2995a90a42ee
unii: 0K5C5T2QPG

Reported adverse events (FAERS/openFDA)#

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