FDA.reportPublic FDA data

NDC 80425-0049-01 - 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
80425-0049
Requested NDC
80425-0049-01
Package NDCs from labels
80425-0049-4, 80425-0049-2, 80425-0049-1, 80425-0049-3, 80425-0049-01
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
80425-0049-1Naproxen60 in 1 BOTTLETABLET608
80425-0049-2Naproxen90 in 1 BOTTLETABLET908
80425-0049-3Naproxen30 in 1 BOTTLETABLET308
80425-0049-4Naproxen120 in 1 BOTTLETABLET1208

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0049NAPROXEN TABLET [ADVANCED RX OF TENNESSEE, LLC]8Current NDC, Legacy NDC, 4 package rows20250101_af9a94a8-3825-eabd-e053-2a95a90acd58.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0049-1EA - Each80425-0049f59baca6-2df7-457a-b759-62a26ac8d37212023-04-07
80425-0049-2EA - Each80425-0049e58110de-d87f-4f2c-992d-e790c9d4b94812023-04-07
80425-0049-3EA - Each80425-004990e9f4b8-c983-428a-af1e-5a9e5ab23cfe12023-04-07
80425-0049-4EA - Each80425-004948b6443c-efb0-41ea-9207-848fc1dcb2b912023-04-07

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 3 of 8 · 144 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMPreferred Pharmaceuticals Inc.b295a90e-320f-4414-b80a-d11f06c00c962026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
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
NaproxenNAPROXENNorthwind Health Company, LLC0de6d673-fa76-e9c0-e063-6394a90a9ded2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
unii: 57Y76R9ATQ
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
application number: ANDA075927
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
application number: ANDA075927
rxcui: 198014
unii: 57Y76R9ATQ
Naproxen SodiumNAPROXEN SODIUMGlenmark Pharmaceuticals Inc., USA6c5bb008-e66f-4ef0-bf84-aca7eb5983e92025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
rxcui: 198013
rxcui: 198012
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
NaproxenNAPROXENSunrise Pharmaceutical, Inc.f2fb222a-b854-4e6f-9027-2e08aed241852025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NAPROXENNAPROXENQPharma Incc0a4839b-7154-c82c-e053-2a95a90a7e6d2025-12-03WarningsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENPHOENIX RX LLC43912294-77c9-eda8-e063-6394a90adf0a2025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENA-S Medication Solutions8c3398bd-66b1-4a14-8aaa-e4a2d6749a082025-11-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENMedcore LLC129392c8-8ce1-4b78-8863-042db880095f2025-10-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NAPROXENNAPROXENPD-Rx Pharmaceuticals, Inc.a9f9ce81-9d51-4167-9581-974866a8fe312025-10-17WarningsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMPreferred Pharmaceuticals Inc.6368a3be-4b79-466b-8ec4-11fc3ac623cc2025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENBryant Ranch Prepacke0f430fd-4511-41c8-b5e9-894abe4f3c372025-10-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ

Reported adverse events (FAERS/openFDA)#

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