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 7 of 22 · 433 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NAPROXENNAPROXENNorthwind Health Company, LLCf32d755e-4984-ee40-e053-2995a90a4ebe2026-01-01WarningsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENNorthwind Health Company, LLCfb07a76b-98ce-85dd-e053-6294a90aa6a82026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENNorthwind Health Company, LLCab6ec2c9-5df9-346c-e053-2a95a90ac81d2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENNorthwind Health Company, LLCdb478961-d984-7c8e-e053-2995a90a8a122026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENNorthwind Health Company, LLCc986ba9a-6f48-8347-e053-2a95a90aa1c12026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENQPharma, Inc.307aa67f-53b9-4c60-a328-091bbf6338d42025-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
Naproxen SodiumNAPROXEN SODIUMGlenmark Pharmaceuticals Inc., USA6c5bb008-e66f-4ef0-bf84-aca7eb5983e92025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078250
ndc (product): 68462-190
rxcui: 849431
rxcui: 849398
rxcui: 198014
rxcui: 198013
rxcui: 198012
spl id: 16372549-a419-4920-a200-5128017570ed
spl set id: 6c5bb008-e66f-4ef0-bf84-aca7eb5983e9
unii: 9TN87S3A3C
unii: 57Y76R9ATQ
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMAjanta Pharma USA Inc.7ca657dc-4376-4693-8568-99351fac81862025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
Naproxen SodiumNAPROXEN SODIUMGranules USA, Inc.8cb8030c-b281-315c-e053-2a95a90a36f02025-12-22WarningsExact identifier
unii: 9TN87S3A3C
Naproxen Sodium Diphenhydramine HCLNAPROXEN SODIUM DIPHENHYDRAMINE HCLWalmartfe810c0e-ab42-5a8a-e053-6394a90affe42025-12-19WarningsExact identifier
unii: 9TN87S3A3C
NaproxenNAPROXENSafeway, Incf2a273f8-d623-dc2f-e053-2995a90a0c022025-12-19WarningsExact identifier
unii: 9TN87S3A3C
Naproxen SodiumNAPROXEN SODIUMSafeway, Incf2a297c2-3898-5e47-e053-2995a90ab3cc2025-12-19WarningsExact identifier
unii: 9TN87S3A3C
Naproxen SodiumNAPROXEN SODIUMTARGET CORPORATIONfdb87abd-3176-dd62-e053-6394a90a6fcc2025-12-19WarningsExact identifier
unii: 9TN87S3A3C
Naproxen Sodium and Diphenhydramine HCLNAPROXEN SODIUM AND DIPHENHYDRAMINE HCLTARGET CORPORATIONfe82699d-fdc2-038e-e053-6294a90a606c2025-12-19WarningsExact identifier
unii: 9TN87S3A3C
Naproxen Sodium Diphenhydramine HClNAPROXEN SODIUM DIPHENHYDRAMINE HCLCVS PHARMACY, INCbdac694e-ab2a-376d-e053-2a95a90a94672025-12-19WarningsExact identifier
unii: 9TN87S3A3C
Naproxen SodiumNAPROXEN SODIUMCVS1042b202-e8ee-1839-e063-6294a90ac90b2025-12-19WarningsExact identifier
unii: 9TN87S3A3C
Naproxen SodiumNAPROXEN SODIUMCVS10429d07-de96-5542-e063-6294a90a73712025-12-19WarningsExact identifier
unii: 9TN87S3A3C
Naproxen Sodium Diphenhydramine HydrochlorideNAPROXEN SODIUM DIPHENHYDRAMINE HYDROCHLORIDESAFEWAYed0f3275-f156-13a3-e053-2a95a90a2ce82025-12-18WarningsExact identifier
unii: 9TN87S3A3C
signature care naproxen sodiumNAPROXEN SODIUMSafeway85f78e63-98aa-4cf3-887d-0ac535184f972025-12-16WarningsExact identifier
unii: 9TN87S3A3C
Naproxen SodiumNAPROXEN SODIUMMEIJER DISTRIBUTION INC89f82399-9f71-49dd-8710-b60f346c576c2025-12-12WarningsExact identifier
unii: 9TN87S3A3C

Reported adverse events (FAERS/openFDA)#

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