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 3 of 4 · 76 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IndomethacinINDOMETHACINBryant Ranch Prepackd54d6e12-e827-4248-819a-de76afa703712025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA201807
rxcui: 310992
unii: XXE1CET956
IndomethacinINDOMETHACINBryant Ranch Prepack67b16cf2-e24c-4fe3-8d74-e63549b7659f2025-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
IndomethacinINDOMETHACINBryant Ranch Prepackb1bb9349-21e4-4e6a-9916-3aac6c4d01b82025-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
IndomethacinINDOMETHACINBryant Ranch Prepack3fd56b7d-2799-4211-9a58-c6c1dc8c70dc2025-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
IndomethacinINDOMETHACINBryant Ranch Prepack2f4a5796-5317-4caa-83e4-0595fe844df42025-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
INDOMETHACININDOMETHACINChartwell RX, LLC9607920c-4d25-40b9-957e-87e9ca5574e82025-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
INDOMETHACININDOMETHACINKVK-Tech, Inc.dc80228c-acae-44dc-9762-19bd1669bf452025-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310992
unii: XXE1CET956
IndomethacinINDOMETHACINAvPAKbcaa0e51-a2fc-cf74-027a-1964e38c5e4e2025-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
Indomethacin ERINDOMETHACINAdvanced Rx Pharmacy of Tennessee, LLCf4e8a719-ef9c-a2ef-e053-2995a90ad7882024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA201807
ndc (package): 80425-0271-1
ndc (product): 80425-0271
ndc11 (package): 80425027101
rxcui: 310992
spl id: 2a9bad62-b300-697c-e063-6294a90aa395
spl set id: f4e8a719-ef9c-a2ef-e053-2995a90ad788
unii: XXE1CET956
IndocinINDOMETHACINZyla Life Sciences US LLC73878376-1d24-423b-9f37-3666e83c95da2024-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
INDOMETHACININDOMETHACINHikma Pharmaceuticals USA Inc.2033059b-4be1-42d0-b888-34d8202f3e092024-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
IndomethacinINDOMETHACINAmneal Pharmaceuticals NY LLC8b48d2b3-61b5-4cfc-a8a0-7ccc235dfe5a2024-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
IndomethacinINDOMETHACINA-S Medication Solutions175a2d81-0d0f-46a3-aaaa-1732982d85fd2024-11-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
IndomethacinINDOMETHACINBryant Ranch Prepack9236d783-d7b8-4486-94c6-5ecd876bc4752024-11-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
IndomethacinINDOMETHACINBryant Ranch Prepack56e19868-3973-4f1b-b80f-1f7daf1f1c222024-11-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
IndomethacinINDOMETHACINZydus Pharmaceuticals USA Inc.7c911ac4-db70-44bf-8374-01c8260aa3d42024-10-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
IndomethacinINDOMETHACINZydus Pharmaceuticals USA Inc.595e2f3e-c6d4-4a17-bc06-46512b4275b52024-10-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
IndomethacinINDOMETHACINBryant Ranch Prepackc6126527-5272-4477-8716-d05365a052252024-08-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA201807
rxcui: 310992
unii: XXE1CET956
IndomethacinINDOMETHACINBryant Ranch Prepack9ce37860-407f-47c7-a64c-62b6cc7292982024-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
IndomethacinINDOMETHACINBryant Ranch Prepackafbb24fd-3695-4a30-a8a6-36239e35a14f2024-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956

Reported adverse events (FAERS/openFDA)#

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