FDA.reportPublic FDA data

NDC 80425-0010-01 - 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
80425-0010
Requested NDC
80425-0010-01
Package NDCs from labels
80425-0010-1, 80425-0010-01
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
80425-0010-1Naproxen60 in 1 BOTTLETABLET605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0010NAPROXEN TABLET [ADVANCED RX OF TENNESSEE, LLC]5Current NDC, Legacy NDC, 1 package rows20250101_af9ad850-57b5-a21d-e053-2a95a90ae68e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0010-1EA - Each80425-00102f16bf83-1509-4482-98a0-e46304552dfb12023-06-06

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 8 · 144 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NaproxenNAPROXENA-S Medication Solutionscfa88511-40bb-4658-b606-44c68d0746b72025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENA-S Medication Solutionsb500bdba-946a-41ff-855c-1f2937547d012025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENAurobindo Pharma Limited570974d4-0d5b-4df2-b307-37380511835d2025-10-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENPD-Rx Pharmaceuticals, Inc.2d01e583-670a-46f4-b5f2-3fad46d0376f2025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENBryant Ranch Prepack124af155-0661-4054-9800-de547d8212d72025-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENZameer Pharmaceuticals LLCd2e5553a-7c90-407c-9f07-3be65560c23a2025-08-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMPHOENIX RX LLC3a652450-525b-4839-e063-6294a90ac2872025-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMPreferred Pharmaceuticals Inc470496f5-a71d-40b2-bf11-3a8d3d7909622025-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMPHOENIX RX LLC3a6637ca-0c55-f648-e063-6294a90aaef72025-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENPD-Rx Pharmaceuticals, Inc.29d98cf3-a0f2-3f89-e054-00144ff88e882025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075927
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENPD-Rx Pharmaceuticals, Inc.6573681e-e9be-440f-a818-a533b744648e2025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075927
rxcui: 198013
unii: 57Y76R9ATQ
NaproxenNAPROXENProficient Rx LPe64b3b36-f96e-463e-aca8-8f6e86724bcf2025-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198013
unii: 57Y76R9ATQ
NaproxenNAPROXENAurobindo Pharma Limited0e5315bc-c02f-4749-be69-b5b528327d582025-06-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
rxcui: 198013
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENAmneal Pharmaceuticals LLCc43a43e2-e867-448d-8f59-3efc7c077cbc2025-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075927
ndc (product): 65162-189
rxcui: 198014
rxcui: 198013
rxcui: 198012
spl id: 691465d4-c26e-4118-9578-bec8d788f33b
spl set id: c43a43e2-e867-448d-8f59-3efc7c077cbc
unii: 57Y76R9ATQ
NaproxenNAPROXENA-S Medication Solutions7fef9311-471b-472c-b4f2-c952a2b3a2552025-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENCamber Pharmaceuticals, Inc.fd5e8d84-f92c-4f4b-ab0d-4cda7cf826bd2025-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENCoupler LLC3375e139-d9de-8c2d-e063-6394a90a653d2025-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENA-S Medication Solutionse63a034d-23ef-458f-88ed-8b6d736996212025-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198013
unii: 57Y76R9ATQ
NaproxenNAPROXENAsclemed USA, Inc.1e406e47-408a-48cc-921e-52882a11581c2025-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
Naproxen Oral SuspensionNAPROXEN ORALANI Pharmaceuticals, Inc.252726a7-757a-4b97-b5b8-ffff4ac1d1032025-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ

Reported adverse events (FAERS/openFDA)#

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