FDA.reportPublic FDA data

NDC 80425-0126-01 - Etodolac ER

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
80425-0126
Requested NDC
80425-0126-01
Package NDCs from labels
80425-0126-1, 80425-0126-01
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
Etodolac ER - 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
80425-0126-1EtodolacER30 in 1 BOTTLETABLET, EXTENDED RELEASE306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0126ETODOLAC ER (ETODOLAC) TABLET, EXTENDED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]6Current NDC, Legacy NDC, 1 package rows20250101_baebdfb2-17f6-9081-e053-2a95a90ab331.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0126-1EA - Each80425-012627df7106-302b-41a0-83af-ae6d695baa3312023-06-06

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 4 of 4 · 73 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EtodolacETODOLACMedsource Pharmaceuticals12f0685b-2127-d0d6-e063-6394a90a62d12024-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACAphena Pharma Solutions - Tennessee, LLC113558e6-8b45-cdbd-e063-6394a90ac0362024-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACAphena Pharma Solutions - Tennessee, LLC1149072a-280a-2b11-e063-6394a90ac1072024-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACAphena Pharma Solutions - Tennessee, LLC420b1ed5-e9f2-43dd-8d3c-ca9896221aca2024-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACA-S Medication Solutions06f602d1-6faf-41c8-bcfd-33e51f4ca6362023-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACProficient Rx LPe2fef939-2f4a-46ae-8177-073f5e8f57f52023-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACA-S Medication Solutions31a55fb1-9721-4202-af7d-f06074b031022023-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACA-S Medication Solutions74baa6ad-b517-48e2-8cef-d77f5755b2792023-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACProficient Rx LP0fce1aea-5de2-4acb-8a21-2b775c4adb252023-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACProficient Rx LP0c783997-6f2a-45ae-b899-c060c8be468a2022-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACDoc Rxcdde46e5-1123-410f-aafc-0c6e904a5d5b2021-09-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACProficient Rx LP4712e069-83b6-4052-8d95-f59ab1dba7442021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310245
unii: 2M36281008
EtodolacETODOLACProficient Rx LP449b273a-936a-4c49-b0c8-d0daa47733ae2019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076174
rxcui: 310245
unii: 2M36281008

Reported adverse events (FAERS/openFDA)#

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