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 6 of 6 · 104 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LansoprazoleLANSOPRAZOLEProficient Rx LP7d811f01-f0c2-4753-bb36-80b48dabb58c2021-01-01Warnings, Adverse reactionsExact identifier
rxcui: 311277
unii: 0K5C5T2QPG
LansoprazoleLANSOPRAZOLECamber Pharmaceuticals, Inc.03b7dceb-2128-4324-b068-7f76a2d9887e2020-06-30Warnings, Adverse reactionsExact identifier
rxcui: 596843
rxcui: 311277
unii: 0K5C5T2QPG
equate lansoprazole delayed releaseLANSOPRAZOLEWal-Mart Stores Inc3eb7a657-625a-46bf-a196-4ba6aa41a7bf2020-05-06WarningsExact identifier
rxcui: 596843
unii: 0K5C5T2QPG
lansoprazoleLANSOPRAZOLEPublix Super Markets Ince226a1eb-39c8-440a-9824-1e5ccddc249e2020-04-14WarningsExact identifier
rxcui: 596843
unii: 0K5C5T2QPG

Reported adverse events (FAERS/openFDA)#

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