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 7 of 8 · 144 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NaproxenNAPROXENA-S Medication Solutionsa8b54258-84e7-41e8-9e51-137a3f442e6b2023-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENA-S Medication Solutions80233fa5-f8b4-42d5-a8c9-4a1d8fd4aba42023-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075927
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENA-S Medication Solutions50c52976-9e04-4a5e-9f21-aca3ea5c29242023-09-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENA-S Medication Solutionsd801ba16-e2ec-4bb2-8cff-32388634b35a2023-09-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENA-S Medication Solutions21930f73-d3c2-4462-a487-74ed871b74b22023-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075927
rxcui: 198013
unii: 57Y76R9ATQ
NaproxenNAPROXENA-S Medication Solutionsa5ea3a84-7acd-4f24-9f0f-9f871ce1b5f42023-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075927
rxcui: 198012
unii: 57Y76R9ATQ
naproxenNAPROXENCipla USA Inc.a9549a47-3fa4-4a2b-95ac-b00e43aedae72023-01-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
rxcui: 198013
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENProficient Rx LPd0670241-f1f9-4fdf-83d4-547e7b8008112022-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NAPROXENNAPROXENAsclemed USA, Inc.a4fcb411-c918-459b-adc6-06dfa8ed8a502022-10-12WarningsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENProficient Rx LPaa4d159c-9cbe-4d29-9532-33a312f1ae052022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198013
unii: 57Y76R9ATQ
NaproxenNAPROXENProficient Rx LP96601d76-50ea-4dc0-b588-d174f8d8bb512022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENAphena Pharma Solutions - Tennessee, LLC98efdeb8-ea38-456e-953f-ba589727f2842021-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENAphena Pharma Solutions - Tennessee, LLC9c963e77-6e05-47d0-a8d3-e581777377b92021-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198013
rxcui: 198012
unii: 57Y76R9ATQ
NAPROXENNAPROXENAphena Pharma Solutions - Tennessee, LLC32693390-763b-46dd-b821-65a7bf3c66712021-04-26WarningsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENProficient Rx LPfc3ee94a-adb7-411e-a662-2f2c6ddbabaf2021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075927
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENProficient Rx LP3e4e5371-d796-47c7-95c1-d99e82a0b2822021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENAphena Pharma Solutions - Tennessee, LLC3e14f839-d1e4-44df-a457-29f005b3e62e2020-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NAPROXENNAPROXENBryant Ranch Prepack5d399bf3-db49-411a-91b9-b410d702a65a2020-12-14WarningsExact identifier
rxcui: 198013
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENExelan Pharmaceuticals, Inc.46dbdb95-a0d0-4410-8d64-b22763b12af72020-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
rxcui: 198013
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENProficient Rx LP69a3afd6-d64b-4f07-b848-b0d3fc19f2a22019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ

Reported adverse events (FAERS/openFDA)#

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