FDA.reportPublic FDA data

NDC 80425-0148-01 - 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
80425-0148
Requested NDC
80425-0148-01
Package NDCs from labels
80425-0148-2, 80425-0148-1, 80425-0148-01
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
80425-0148-1LansoprazoleDR30 in 1 BOTTLECAPSULE, DELAYED RELEASE306
80425-0148-2LansoprazoleDR60 in 1 BOTTLECAPSULE, DELAYED RELEASE606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0148LANSOPRAZOLE DR (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]6Current NDC, Legacy NDC, 2 package rows20250101_c77da981-9260-fabd-e053-2a95a90aa71c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0148-1EA - Each80425-0148e2277101-3e43-41e4-8411-41d918ce09bc12023-06-06
80425-0148-2EA - Each80425-0148718c791b-ef6b-43b3-9316-78a147de838012023-06-06

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 6 · 104 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LansoprazoleLANSOPRAZOLEWalgreen Companya72f92cc-db49-40ef-a249-6b7c50dc8ef22026-02-28WarningsExact identifier
unii: 0K5C5T2QPG
LansoprazoleLANSOPRAZOLEMedcore LLC18b4020f-d7e6-42f8-838d-2b5da152530e2026-01-16Warnings, Adverse reactionsExact identifier
rxcui: 311277
unii: 0K5C5T2QPG
LansoprazoleLANSOPRAZOLEPreferred Pharmaceuticals Inc.960d6601-aec5-4900-a400-385b6687a4bc2026-01-12Warnings, Adverse reactionsExact identifier
application number: ANDA091269
rxcui: 596843
unii: 0K5C5T2QPG
good neighbor pharmacy lansoprazoleLANSOPRAZOLEAmerisource Bergena4ee8db4-8f8e-4326-bd32-43abd53be8e42025-12-01WarningsExact identifier
rxcui: 596843
unii: 0K5C5T2QPG
LansoprazoleLANSOPRAZOLEMylan Institutional Inc.eea82d0b-6600-4693-a2b8-596a55458f612025-11-11Warnings, Adverse reactionsExact identifier
rxcui: 311277
unii: 0K5C5T2QPG
LansoprazoleLANSOPRAZOLEAjanta Pharma USA Inc.6b9c60e9-b0d2-4aec-a04b-ccc7a62c822b2025-11-10Warnings, Adverse reactionsExact identifier
rxcui: 596843
rxcui: 311277
unii: 0K5C5T2QPG
LansoprazoleLANSOPRAZOLEBryant Ranch Prepacke7a3aa37-9c9b-43fe-92be-6e0fdc8d1c922025-10-28Warnings, Adverse reactionsExact identifier
application number: ANDA091269
rxcui: 596843
unii: 0K5C5T2QPG
LansoprazoleLANSOPRAZOLEA-S Medication Solutions3babf7d9-ad83-4e44-8e5d-f6c11b2d76b62025-09-05Warnings, Adverse reactionsExact identifier
rxcui: 311277
unii: 0K5C5T2QPG
LansoprazoleLANSOPRAZOLEA-S Medication Solutions16dc1e02-4679-4d7f-a65b-6e3706655d352025-09-05Warnings, Adverse reactionsExact identifier
rxcui: 311277
unii: 0K5C5T2QPG
LansoprazoleLANSOPRAZOLERite Aid Corporation5f256a0c-14df-4fd9-a818-b4276954152e2025-08-25WarningsExact identifier
rxcui: 596843
unii: 0K5C5T2QPG
LansoprazoleLANSOPRAZOLECVS Pharmacyd52b26e2-3d2a-4067-a28b-8697f865f5822025-08-20WarningsExact identifier
rxcui: 596843
unii: 0K5C5T2QPG
LansoprazoleLANSOPRAZOLEChain Drug Marketing Association74417c65-cccd-5a6a-0f96-0d8cb5a1592a2025-07-18WarningsExact identifier
rxcui: 596843
unii: 0K5C5T2QPG
LansoprazoleLANSOPRAZOLEWalgreens company277093d5-cd0f-36ad-63d4-824a62d2a16c2025-07-18WarningsExact identifier
rxcui: 596843
unii: 0K5C5T2QPG
LansoprazoleLANSOPRAZOLEAscend Laboratories, LLC9e246e79-2737-4cbb-ad5d-4e76893da3be2025-07-17Warnings, Adverse reactionsExact identifier
rxcui: 596843
rxcui: 311277
unii: 0K5C5T2QPG
PrevacidLANSOPRAZOLETakeda Pharmaceuticals America, Inc.71ba78cb-7e46-43eb-9425-fa130f537f842025-07-08Warnings, Adverse reactionsExact identifier
rxcui: 311277
unii: 0K5C5T2QPG
Prevacid 24 HRLANSOPRAZOLEL. Perrigo Company205c9c1e-b422-4e86-a4b0-714b608adc192025-06-24WarningsExact identifier
rxcui: 596843
unii: 0K5C5T2QPG
LansoprazoleLANSOPRAZOLENuCare Pharmaceuticals,Inc.37b221ee-b6a4-76e8-e063-6394a90a7e0b2025-06-13Warnings, Adverse reactionsExact identifier
rxcui: 311277
unii: 0K5C5T2QPG
lansoprazoleLANSOPRAZOLEMeijer Distribution Incb202a695-4265-4b3b-bab8-593d479623822025-06-12WarningsExact identifier
rxcui: 596843
unii: 0K5C5T2QPG
lansoprazoleLANSOPRAZOLEWalgreen Companyafcd7c51-9333-4d6f-ad18-ed95baecc7ce2025-05-12WarningsExact identifier
rxcui: 596843
unii: 0K5C5T2QPG
up and up lansoprazoleLANSOPRAZOLETarget Corporation16ceaead-8dc0-49de-9438-caa146e13fba2025-04-13WarningsExact identifier
rxcui: 596843
unii: 0K5C5T2QPG

Reported adverse events (FAERS/openFDA)#

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