FDA.reportPublic FDA data

NDC 80425-0271-01 - Indomethacin 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
80425-0271
Requested NDC
80425-0271-01
Package NDCs from labels
80425-0271-1, 80425-0271-01
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
Indomethacin 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
80425-0271-1IndomethacinER60 in 1 BOTTLECAPSULE, EXTENDED RELEASE602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0271INDOMETHACIN ER (INDOMETHACIN) CAPSULE, EXTENDED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 1 package rows20250102_f4e8a719-ef9c-a2ef-e053-2995a90ad788.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0271-1EA - Each80425-02711555989f-c09b-4c27-9122-5e808518bed512023-04-07

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 · 76 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IndomethacinINDOMETHACINA-S Medication Solutions927af761-2f37-4e81-a86e-d4fb17cc18972026-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
IndomethacinINDOMETHACINNorthwind Health Company, LLCc9f4eda2-5c8f-72eb-e053-2a95a90a06be2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
IndomethacinINDOMETHACINNorthwind Health Company, LLCf2f59f63-fcda-2a80-e053-2995a90ab0872026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA201807
rxcui: 310992
unii: XXE1CET956
IndomethacinINDOMETHACINNorthwind Health Company, LLCdb0f1127-ebd8-636c-e053-2a95a90a4d442026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
IndomethacinINDOMETHACINNorthwind Health Company, LLCdffe9b95-3cb6-4c4e-e053-2a95a90a93282026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
IndomethacinINDOMETHACINNorthStar RxLLC6bb30cef-c460-4696-8acd-a453408640f42025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
IndomethacinINDOMETHACINGlenmark Pharmaceuticals Inc., USAf7ed39e2-5431-4e47-935c-c7441d058f942025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
INDOCININDOMETHACINZyla Life Sciences US Inc.3b36645c-de5e-4263-ae06-2f6ff6a9add22025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
IndomethacinINDOMETHACINChartwell RX, LLCd35bafd6-076d-4b94-bb0f-99be0addb5052025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
indomethacinINDOMETHACINGlenmark Pharmaceuticals Inc., USA532d40b2-c05c-4d4f-b7ee-e6434c4c27fc2025-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310992
unii: XXE1CET956
IndomethacinINDOMETHACINPreferred Pharmaceuticals Inc.971c4d53-7876-4f42-ba2d-c391714fa3412025-11-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
IndomethacinINDOMETHACINAmerican Health Packaging5a65b650-ea9b-4d0d-b62f-5971df1e62b42025-10-28Warnings, Adverse reactionsExact identifier
rxcui: 310992
unii: XXE1CET956
IndomethacinINDOMETHACINA-S Medication Solutions5b05b8bc-4df0-4175-bf53-72129fb21b502025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
IndomethacinINDOMETHACINBryant Ranch Prepacka329976b-4a01-42ea-a666-0ac99ed2522e2025-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
IndomethacinINDOMETHACINBryant Ranch Prepackefa111d5-ade4-4944-97e4-3c37b8b14ea82025-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA201807
rxcui: 310992
unii: XXE1CET956
IndomethacinINDOMETHACINCamber Pharmaceuticals, Inc.c81343f2-5ef5-4635-9b94-5ac8d72aa61e2025-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
IndomethacinINDOMETHACINCamber Pharmaceuticals, Inc.1ce9c3c5-0cf7-4760-988d-2559adcfb2002025-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
IndomethacinINDOMETHACINCamber Pharmaceuticals, Inc.12f62bae-5fc0-4f8d-a8b4-446524bd53d12025-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA201807
ndc (product): 31722-565
rxcui: 310992
spl id: 349e2ce2-f399-926c-e063-6294a90a9185
spl set id: 12f62bae-5fc0-4f8d-a8b4-446524bd53d1
unii: XXE1CET956
INDOMETHACININDOMETHACINPD-Rx Pharmaceuticals, Inc.85014b51-1354-4d16-9995-3ee33a7155fa2025-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310992
unii: XXE1CET956
IndomethacinINDOMETHACINBryant Ranch Prepack4cc7ef3b-fddd-49dd-85d1-cbb3d5c17ff72025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956

Reported adverse events (FAERS/openFDA)#

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