FDA.reportPublic FDA data

NDC 80425-0306-01 - Mefenamic Acid

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
80425-0306
Requested NDC
80425-0306-01
Package NDCs from labels
80425-0306-1, 80425-0306-2, 80425-0306-3, 80425-0306-01
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
Mefenamic Acid - 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
80425-0306-1Mefenamic Acid30 in 1 BOTTLECAPSULE302
80425-0306-2Mefenamic Acid60 in 1 BOTTLECAPSULE602
80425-0306-3Mefenamic Acid90 in 1 BOTTLECAPSULE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0306MEFENAMIC ACID CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_f8b1a4a2-83fc-6b4b-e053-6394a90ac46a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0306-1EA - Each80425-0306dcf74e20-fdb3-4393-b80f-bb34e649da6112023-06-06
80425-0306-2EA - Each80425-03060680efaa-6c6c-47df-9f0e-47ebdc0851fd12023-06-06
80425-0306-3EA - Each80425-0306f88b4fa9-824f-4606-9931-d7c5f3c6eceb12023-06-06

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 1 ยท 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mefenamic AcidMEFENAMIC ACIDLupin Pharmaceuticals, Inc.d15733a9-d5fd-4d5f-86ce-e7ed8c706c7f2026-04-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 829500
unii: 367589PJ2C
Mefenamic acidMEFENAMIC ACIDBryant Ranch Prepack9b8b3e03-4801-4ae8-b44e-e01d1ab1e34b2026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090562
rxcui: 829500
unii: 367589PJ2C
Mefenamic AcidMEFENAMIC ACIDMisemer Pharmaceuticals, Incd0291319-ab3e-20c8-e053-2a95a90afabb2026-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 829500
unii: 367589PJ2C
Mefenamic acidMEFENAMIC ACIDMicro Labs Limited4b0788cd-bdca-4fa5-9eba-01a270613aab2026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090562
ndc (product): 42571-258
rxcui: 829500
spl id: 482b411c-8d6f-8690-e063-6294a90af95f
spl set id: 4b0788cd-bdca-4fa5-9eba-01a270613aab
unii: 367589PJ2C
Mefenamic AcidMEFENAMIC ACIDAdvanced Rx Pharmacy of Tennessee, LLCf8b1a4a2-83fc-6b4b-e053-6394a90ac46a2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090562
ndc (package): 80425-0306-1
ndc (package): 80425-0306-2
ndc (package): 80425-0306-3
ndc (product): 80425-0306
ndc11 (package): 80425030601
rxcui: 829500
spl id: 2a9ba8f4-6cef-e827-e063-6394a90a0300
spl set id: f8b1a4a2-83fc-6b4b-e053-6394a90ac46a
unii: 367589PJ2C
Mefenamic AcidMEFENAMIC ACIDAdvanced Rx of Tennessee, LLC1e927779-411a-b5f5-e063-6394a90aae932024-07-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 829500
unii: 367589PJ2C

Reported adverse events (FAERS/openFDA)#

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