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 1 of 4 · 73 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EtodolacETODOLACREMEDYREPACK INC.188cdd2e-4196-458c-9631-4fa9a0d309b82026-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
etodolacETODOLACA-S Medication Solutions1e04a6b7-a671-4999-ab03-aa1a243aac032026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACBryant Ranch Prepackea12933b-2280-4a11-a0e3-554194c53c4d2026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACBryant Ranch Prepack03458123-e27c-4447-9ef3-3bd32481cb972026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACGolden State Medical Supply, Inc.cf17926c-ed90-4fd0-80af-ccee084075e82026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACGolden State Medical Supply, Inc.c59c5108-a09b-2a03-e053-2995a90abba12026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076174
rxcui: 310245
rxcui: 310247
rxcui: 359500
unii: 2M36281008
EtodolacETODOLACAurobindo Pharma Limitedc74c3c56-a5ac-40b4-974b-c4f4b05c5df92026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACSun Pharmaceutical Industries, Inc.ec82b108-6a6f-4d1b-82cb-831d4ed36c802026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACTaSun Pharmaceutical Industries, Inc.2c5b44b4-78d5-43b2-827d-d2763b6672b32026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076174
rxcui: 310245
rxcui: 310247
rxcui: 359500
unii: 2M36281008
EtodolacETODOLACSt. Marys Medical Park Pharmacy60cb4de0-ed88-a46b-e053-2a91aa0a8b6d2026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACREMEDYREPACK INC.cad9b5ca-a9d4-41d4-aff2-67d0c458aad62026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACPD-Rx Pharmaceuticals, Inc.007c55fa-ef8b-4a8e-bfe5-e47c6e5da7272026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACSt. Mary's Medical Park Pharmacy6761e6b1-2399-4643-e053-2991aa0a6f172026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 359500
unii: 2M36281008
EtodolacETODOLACPD-Rx Pharmaceuticals, Inc.41bd86b9-2ef3-49a4-874e-fe8ac68910802026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACPD-Rx Pharmaceuticals, Inc.556eaa67-d30d-4095-a981-c65f98d3acdd2026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACPreferred Pharmaceuticals Inc.117b3005-a8ec-4f76-824c-95ec42dc87a12026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACPreferred Pharmaceuticals Inc.55ae2e78-d803-496b-b66d-af11403127852026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACBryant Ranch Prepack301087e4-f05c-4fd3-8815-c86c6f12ff612026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACBryant Ranch Prepacka355160d-24c3-4a4d-99ea-84c80ce67f902026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACBryant Ranch Prepacke7a81661-28a2-40d7-8c90-786629c81e362026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008

Reported adverse events (FAERS/openFDA)#

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