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 2 of 4 · 73 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
etodolacETODOLACIpca Laboratories Limitedf50a93ca-584a-4205-a79b-31bafdd309c22026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
etodolacETODOLACIpca Laboratories Limitedd583988c-3e7e-4415-b2fd-34049791cd1c2026-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACA-S Medication Solutions336d5331-4d60-42e2-8cfc-aad57c01eda02026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACA-S Medication Solutions00125d63-d8d0-46c5-bdf1-80d2c85eda5a2026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACA-S Medication Solutions4d392c1b-95c2-4925-98bf-0203c412d3da2026-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACNorthwind Health Company, LLC7ec87ffd-057e-420c-b8f2-0a6eed4152be2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACNorthwind Health Company, LLCb0880f39-a6fa-23ab-e053-2995a90a7eb22026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACNorthwind Health Company, LLCda34581d-3066-711c-e053-2995a90a8e842026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACANI Pharmaceuticals, Inc.420c7b62-3bea-4d6b-82e0-ab1c176c7f1e2025-12-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACEdenbridge Pharmaceuticals LLC.bf1afcd5-e1da-4874-981f-f252cb0b32c22025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACPD-Rx Pharmaceuticals, Inc.80e9d756-9278-48bb-bfdd-7d070ae0f3412025-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACChartwell RX, LLCf86d2b22-d3f7-49cd-98f6-cdb2bd8551922025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACUnichem Pharmaceuticals (USA), Inc.18215cb7-c833-4a98-a61d-4bedf518a3802025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACBryant Ranch Prepack479bce92-2066-46ed-b4bb-8c7a59edfffd2025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACBryant Ranch Prepack5e94a98f-d36e-4f28-b79c-6ad8a67933812025-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACApotex Corp.4d682f98-1e8a-4c2b-6df3-169d2ed10dc12025-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACAdvanced Rx of Tennessee, LLC3d865ff0-fc45-1e95-e063-6294a90a8e182025-08-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACNORTHSTAR RX LLC107ea9d7-80a9-41a4-b61e-1683701273192025-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076174
ndc (product): 16714-499
rxcui: 310245
rxcui: 310247
rxcui: 359500
spl id: 38568f45-b334-0e6f-e063-6294a90a178a
spl set id: 107ea9d7-80a9-41a4-b61e-168370127319
unii: 2M36281008
EtodolacETODOLACPreferred Pharmaceuticals Inc.556a7d5f-2c3c-4efb-ac0c-fca1407916022025-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACA-S Medication Solutionsa7d91fcf-7928-4c9e-862b-6922d6e47c9d2025-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008

Reported adverse events (FAERS/openFDA)#

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