FDA.reportPublic FDA data

NDC 80425-0050-01 - Naproxen

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
80425-0050
Requested NDC
80425-0050-01
Package NDCs from labels
80425-0050-2, 80425-0050-1, 80425-0050-01
Manufacturer
Advanced Rx 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
Naproxen - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0050-1Naproxen60 in 1 BOTTLETABLET606
80425-0050-2Naproxen90 in 1 BOTTLETABLET906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0050NAPROXEN TABLET [ADVANCED RX OF TENNESSEE, LLC]6Current NDC, Legacy NDC, 2 package rows20250101_af9aa7a0-e287-5935-e053-2995a90a1d11.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0050-1EA - Each80425-005042db3f9d-30eb-4317-9ff5-cacb1fe8161e12023-06-06
80425-0050-2EA - Each80425-0050d33960a5-6523-4a80-b4e6-0fa5094a6aad12023-06-06

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 4 of 22 · 433 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medique MediproxenNAPROXEN SODIUMSportpharm LLCf01adfcc-b32a-4a98-a4e7-2ce87b824b5a2026-04-24WarningsExact identifier
unii: 9TN87S3A3C
NaproxenNAPROXENBryant Ranch Prepackf18181f4-6b14-48a8-a149-e45b3360a2502026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198013
unii: 57Y76R9ATQ
NaproxenNAPROXENCameron Pharmaceuticals2ae474dd-eaae-4401-8d42-613d672daea02026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENBryant Ranch Prepack97d6c4ef-13b1-4b0b-a15a-f0590019940d2026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENBryant Ranch Prepack852fed15-e78b-47a8-aeb4-623dfe1edad92026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENREMEDYREPACK INC.6bb65680-76ea-46e5-ae70-f3091e3603682026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENREMEDYREPACK INC.12202ef3-c65e-45a6-88ed-5d945d8fd41c2026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
AleveNAPROXEN SODIUMNavajo Manufacturing Company Inc.590f3be2-20df-4643-9114-e7ed4cf9155c2026-04-08WarningsExact identifier
unii: 9TN87S3A3C
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMProficient Rx LP5fd008ef-8388-48e9-8d38-76e0106bd5b62026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENRadha Pharmaceuticals, Inc.1a2b9a82-5b79-45ee-94ed-7a6f8c8b51702026-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
rxcui: 198013
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENAvPAKe6fbf8f1-b064-658d-17bb-e7d6320aa45f2026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
rxcui: 198013
rxcui: 198012
unii: 57Y76R9ATQ
Rapidol NaproxenNAPROXEN SODIUMPharmadel LLCc94c4b6e-a48b-cee5-e053-2995a90a49ac2026-03-20WarningsExact identifier
unii: 9TN87S3A3C
Naproxen Sodium 220mgNAPROXEN SODIUM 220MGGrocery Outlet1f5b5c55-44df-4872-8c74-b8a812efc32a2026-03-18WarningsExact identifier
unii: 9TN87S3A3C
NaproxenNAPROXENScieGen Pharmaceuticals, Inc.81e22c1f-f94d-46e9-8b7d-72dc2518319e2026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
rxcui: 198013
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENNuCare Pharmaceuticals,Inc.c136cf75-4ad4-8634-e053-2a95a90a53a42026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
Aleve CapletsNAPROXEN SODIUMBayer HealthCare LLC.02941928-128a-2c88-e063-6294a90ac6ba2026-03-12WarningsExact identifier
unii: 9TN87S3A3C
Naproxen SodiumNAPROXEN SODIUMWalgreensd9806ad8-1cea-4599-97ef-a956ec7f0e212026-03-11WarningsExact identifier
unii: 9TN87S3A3C
Naproxen Back and Muscle PainNAPROXEN SODIUML.N.K. International, Inc.68944663-0dc0-4d3a-a36b-019061bdbfa02026-03-09WarningsExact identifier
unii: 9TN87S3A3C
AnaDentNAPROXEN SODIUMBelmora LLC236674db-da4d-415c-a160-7086eaf5bff52026-03-03WarningsExact identifier
unii: 9TN87S3A3C
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMPHOENIX RX LLC4c25c106-b5ca-079f-e063-6394a90a49782026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ

Reported adverse events (FAERS/openFDA)#

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