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 3 of 4 · 73 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Etodolac ERETODOLACAdvanced Rx Pharmacy of Tennessee, LLCd294d541-3049-6bfe-e053-2995a90a23ea2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076174
rxcui: 310247
unii: 2M36281008
EtodolacETODOLACAdvanced Rx Pharmacy of Tennessee, LLCd83d9f30-c367-f8b3-e053-2a95a90a1f402024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACAdvanced Rx Pharmacy of Tennessee, LLCc18497e2-9fca-4500-e053-2a95a90a1bcc2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
Etodolac ERETODOLACAdvanced Rx Pharmacy of Tennessee, LLCbaebdfb2-17f6-9081-e053-2a95a90ab3312024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076174
ndc (package): 80425-0126-1
ndc (product): 80425-0126
ndc11 (package): 80425012601
rxcui: 310247
spl id: 2a99bd40-3c4c-3207-e063-6294a90a4faa
spl set id: baebdfb2-17f6-9081-e053-2a95a90ab331
unii: 2M36281008
EtodolacETODOLACNuCare Pharmaceuticals, Inc.27e98e6d-9fad-3a94-e063-6394a90a1dcb2024-12-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310245
unii: 2M36281008
EtodolacETODOLACZydus Lifesciences Limited0c5f8631-f013-4bbb-b610-0a8a1311844e2024-11-28Exact identifier
rxcui: 310245
rxcui: 310247
rxcui: 359500
unii: 2M36281008
EtodolacETODOLACAphena Pharma Solutions - Tennessee, LLC2425aef0-57eb-d1a5-e063-6294a90a0bf22024-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACBryant Ranch Prepack1e4824cc-4d52-4f20-9674-cfcb9ee665742024-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310247
unii: 2M36281008
EtodolacETODOLACProficient Rx LP5a040d8e-8d0c-442f-b4e5-161aa7ccbe9a2024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310245
unii: 2M36281008
EtodolacETODOLACZydus Pharmaceuticals USA Inc.7ef79e43-0628-4795-937e-ebb752d791332024-09-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310245
rxcui: 310247
rxcui: 359500
unii: 2M36281008
EtodolacETODOLACBryant Ranch Prepackbe53bc5c-4294-44a7-b28c-7db3f925396d2024-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACBryant Ranch Prepackb7f7c4a4-6245-43e1-af40-fcf61abbc64e2024-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACBryant Ranch Prepackdbaa1202-1ade-4471-96fb-4b951b3862342024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACAmneal Pharmaceuticals NY LLC2f306e69-c109-4e60-aaf3-9016a4e2cc332024-07-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACTeva Pharmaceuticals USA, Inc.f3bf1675-8fda-40d3-8427-0a6a6133a3d32024-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310245
rxcui: 310247
rxcui: 359500
unii: 2M36281008
EtodolacETODOLACBryant Ranch Prepack4b0d1245-8d01-4fff-9783-cb30c17d92462024-05-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACAdvanced Rx Pharmacy of Tennessee, LLC15d6bc8e-1e25-6676-e063-6294a90a00352024-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310247
unii: 2M36281008
EtodolacETODOLACBryant Ranch Prepack53160db5-ba48-4cac-afbe-acd608daa0dc2024-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACAphena Pharma Solutions - Tennessee, LLC1547f132-0d35-45cb-e063-6294a90a2efe2024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACAphena Pharma Solutions - Tennessee, LLC141be3f6-198d-ce46-e063-6294a90a79932024-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008

Reported adverse events (FAERS/openFDA)#

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