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 6 of 22 · 433 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Care One Naproxen SodiumNAPROXEN SODIUMAmerican Sales Companybc5ddcf2-640c-4683-a60f-ca1c8b4188732026-01-29WarningsExact identifier
unii: 9TN87S3A3C
NaproxenNAPROXENA-S Medication Solutions000155a8-709c-44e5-a75f-cd890f3a7caf2026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078250
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENA-S Medication Solutionsd06db628-f6f0-48e2-b538-69c0837c49e32026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078250
rxcui: 198014
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENA-S Medication Solutions9d28422f-6f25-4f14-9272-e0907c971f332026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078250
rxcui: 849431
rxcui: 198014
rxcui: 198012
unii: 57Y76R9ATQ
Naproxen SodiumNAPROXEN SODIUMBryant Ranch Prepack1c2325f7-1d65-429d-a64d-6ab075df1c202026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 849398
unii: 9TN87S3A3C
Flanax Menstrual Pain RelieverNAPROXEN SODIUMBelmora LLC2b4135b3-389c-46e2-ae86-7674c2ab9a322026-01-27WarningsExact identifier
unii: 9TN87S3A3C
BACK AND MUSCLE PAINNAPROXENWALGREENS81417810-8a34-c859-e053-2a91aa0a65072026-01-26WarningsExact identifier
unii: 9TN87S3A3C
Leader All Day Pain ReliefNAPROXEN SODIUMCardinal Health 110, LLC. dba Leaderdbf007f5-c792-43a7-8cc1-bfa617f3a7fa2026-01-26WarningsExact identifier
unii: 9TN87S3A3C
NaproxenNAPROXENPreferred Pharmaceuticals Inc.87acd650-ea8a-4396-be72-5568c4b1755c2026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078250
rxcui: 198014
unii: 57Y76R9ATQ
naproxen sodiumNAPROXEN SODIUMMeijer Distribution Incf4e57560-ae89-4fc3-a66b-ebf3dc3f24482026-01-22WarningsExact identifier
unii: 9TN87S3A3C
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMPreferred Pharmaceuticals Inc.b295a90e-320f-4414-b80a-d11f06c00c962026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
Naproxen SodiumNAPROXEN SODIUMHYVEE INC45a0c910-7dd7-6a42-e063-6394a90a491c2026-01-13WarningsExact identifier
unii: 9TN87S3A3C
Naproxen SodiumNAPROXEN SODIUMHYVEE INC45a00020-173b-a4a1-e063-6294a90ae3992026-01-13WarningsExact identifier
unii: 9TN87S3A3C
NaprelanNAPROXEN SODIUMUpsher-Smith Laboratories, LLCb8a51c9a-488e-4377-a041-436f6a2f88932026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9TN87S3A3C
FlanaxNAPROXEN SODIUMBelmora LLC2c099d45-f03a-4161-a6af-8fe5965f27482026-01-06WarningsExact identifier
unii: 9TN87S3A3C
NaproxenNAPROXENAcella Pharmaceuticals, LLC7e6f03fb-4b36-4418-9684-f45637abbb782026-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENPD-Rx Pharmaceuticals, Inc.fa2fe6fd-c476-dd29-e053-6294a90a9e9e2026-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
Naproxen SodiumNAPROXEN SODIUMPD-Rx Pharmaceuticals, Inc.145cdcc0-9bd5-4a0e-81fc-11a24d1819802026-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 849431
unii: 9TN87S3A3C
Naproxen SodiumNAPROXEN SODIUMSafeway, Inc.deb1be0f-64ae-46b5-b54a-1a58eec6492e2026-01-05WarningsExact identifier
unii: 9TN87S3A3C
NaproxenNAPROXENNorthwind Health Company, LLC0de6d673-fa76-e9c0-e063-6394a90a9ded2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
unii: 57Y76R9ATQ

Reported adverse events (FAERS/openFDA)#

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