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 4 of 4 · 76 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IndomethacinINDOMETHACINNuCare Pharmaceuticals, Inc.3e87e34a-6556-4b0f-e054-00144ff8d46c2024-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
IndomethacinINDOMETHACINNuCare Pharmaceuticals, Inc.3e8796a6-94c6-0db2-e054-00144ff88e882024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
IndomethacinINDOMETHACINAmneal Pharmaceuticals LLCdbad7e61-2347-43b1-a422-9183e41c10ea2024-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310992
unii: XXE1CET956
IndomethacinINDOMETHACINNuCare Pharmaceuticals, Inc.503455d9-471e-554f-e054-00144ff88e882024-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
INDOMETHACININDOMETHACINDIRECT RX4d9a253a-f014-4fab-e054-00144ff8d46c2024-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
IndomethacinINDOMETHACINZydus Lifesciences Limitedc6ca86fb-df23-42c1-9d29-f15312faf60c2023-08-03Exact identifier
unii: XXE1CET956
IndomethacinINDOMETHACINProficient Rx LPac458b4b-95bb-4235-a447-e8c4ba7202572023-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA201807
rxcui: 310992
unii: XXE1CET956
IndomethacinINDOMETHACINFresenius Kabi USA, LLC30e38747-c553-4e2d-bc23-634e1dd90b8d2023-06-16Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
IndomethacinINDOMETHACINFresenius Kabi USA, LLCdd5caa3f-3c09-4034-bf43-2df80c61c07b2023-06-01Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
IndomethacinINDOMETHACINXLCare Pharmaceuticals Inc.bc8a572d-e0e1-4d37-b3c4-b85415d503932023-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
IndomethacinINDOMETHACINProficient Rx LP66e3205b-eab1-4864-bf36-116e9d79fe3e2023-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
IndomethacinINDOMETHACINAsclemed USA, Inc.dfdcdb27-07a0-47e6-b8da-d9c99045a0662022-10-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA201807
rxcui: 310992
unii: XXE1CET956
IndomethacinINDOMETHACINProficient Rx LP86c94559-b453-4e61-a76c-6962872f06552022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
IndomethacinINDOMETHACINProficient Rx LPb094eb04-3177-431d-b5ac-edc4804750a22022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
IndomethacinINDOMETHACINAsclemed USA, Inc.9c15102c-b6f9-4198-b592-1521605910142022-07-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956
IndomethacinINDOMETHACINProficient Rx LP8aa48212-19b0-4304-9c61-dcf4db2b19ea2022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: XXE1CET956

Reported adverse events (FAERS/openFDA)#

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