FDA.reportPublic FDA data

NDC 80425-0378-01 - 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
80425-0378
Requested NDC
80425-0378-01
Package NDCs from labels
80425-0378-1, 80425-0378-2, 80425-0378-3, 80425-0378-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-03-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Naproxen - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-03-21HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0378-1Naproxen30 in 1 BOTTLETABLET301
80425-0378-2Naproxen60 in 1 BOTTLETABLET601
80425-0378-3Naproxen90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0378NAPROXEN TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]1Current NDC, 3 package rows20240322_1431b769-5535-78d6-e063-6394a90a8423.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0378-1EA - Each80425-0378387b65e2-7bdd-4a8e-979e-912308ac18d912024-04-05
80425-0378-2EA - Each80425-0378cdc2c520-a361-4582-9368-034ccf67b71812024-04-05
80425-0378-3EA - Each80425-037818e03221-0151-4b55-8081-6b6081b3d7b212024-04-05

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 11 · 204 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMProficient Rx LP5fd008ef-8388-48e9-8d38-76e0106bd5b62026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENRadha Pharmaceuticals, Inc.1a2b9a82-5b79-45ee-94ed-7a6f8c8b51702026-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA212517
rxcui: 198014
rxcui: 198013
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENAvPAKe6fbf8f1-b064-658d-17bb-e7d6320aa45f2026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
rxcui: 198013
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENScieGen Pharmaceuticals, Inc.81e22c1f-f94d-46e9-8b7d-72dc2518319e2026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA212517
ndc (product): 50228-436
rxcui: 198014
rxcui: 198013
rxcui: 198012
spl id: 9af8c9f3-92e7-4301-b401-f40230af2eb7
spl set id: 81e22c1f-f94d-46e9-8b7d-72dc2518319e
unii: 57Y76R9ATQ
NaproxenNAPROXENNuCare Pharmaceuticals,Inc.c136cf75-4ad4-8634-e053-2a95a90a53a42026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA212517
rxcui: 198014
unii: 57Y76R9ATQ
Leader Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLCardinal Health5c5d6c13-9b51-48f0-8627-b60b0f707fd32026-03-12WarningsExact identifier
unii: FZ989GH94E
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMPHOENIX RX LLC4c25c106-b5ca-079f-e063-6394a90a49782026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENAurobindo Pharma Limited67815abd-5e97-4ccb-ac9b-28c2ef6123e72026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLSportpharm LLC8d58dcbb-72a0-41f0-9eeb-613072a6d7ae2026-02-06WarningsExact identifier
unii: FZ989GH94E
MINIDROPSLUBRICANT EYE DROPSOptics Laboratory, Incc13c5f91-50df-471c-a7c9-1747a2ac12502026-02-03WarningsExact identifier
unii: FZ989GH94E
NaproxenNAPROXENA-S Medication Solutions4e97e645-552d-424b-990a-f94349a86f172026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENA-S Medication Solutions000155a8-709c-44e5-a75f-cd890f3a7caf2026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENA-S Medication Solutionsd06db628-f6f0-48e2-b538-69c0837c49e32026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENA-S Medication Solutions9d28422f-6f25-4f14-9272-e0907c971f332026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENPreferred Pharmaceuticals Inc.87acd650-ea8a-4396-be72-5568c4b1755c2026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
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
application number: ANDA212517
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

Reported adverse events (FAERS/openFDA)#

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