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 6 of 8 · 144 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NaprotinNAPROXEN , CAPSAICINPureTek Corporationdc2d2783-2a73-cb7c-e053-2995a90a99612024-12-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NaproxenNAPROXENAmneal Pharmaceuticals NY LLC985aedc1-8b3c-4cb4-af13-7203a2b57ab72024-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENMARKSANS PHARMA LIMITED1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c82024-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
rxcui: 198013
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENBryant Ranch Prepackda61463f-f87b-4aba-b538-7264252cadb82024-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198013
unii: 57Y76R9ATQ
NaproxenNAPROXENBryant Ranch Prepack1fe9a6fc-940e-4a18-b3e9-b204fd67f2632024-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENBoswell Pharmacy Services LLC d/b/a BPS Wholesale205b1159-06e5-0d48-e063-6294a90acbd82024-08-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENBryant Ranch Prepacka4f31070-4ee1-4d64-8b1d-40b9011e124b2024-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075927
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENNuCare Pharmaceuticals,Inc.5e873524-f9fb-fe2d-e053-2991aa0aa0a52024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENNuCare Pharmaceuticals, Inc.46dd3908-6feb-4f50-e054-00144ff88e882024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENNuCare Pharmaceuticals, Inc.3e8bcc59-dab1-1b4c-e054-00144ff88e882024-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NAPROXENNAPROXENNuCare Pharmaceuticals,Inc.5487dee2-5c37-4348-e054-00144ff8d46c2024-07-17WarningsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NAPROXENNAPROXENNuCare Pharmaceuticals,Inc.71d4a048-ca50-73db-e053-2a95a90ad4652024-06-10WarningsExact identifier
rxcui: 198013
unii: 57Y76R9ATQ
NAPROXENNAPROXENNuCare Pharmaceuticals,Inc.69366b55-2687-17a4-e053-2a91aa0a65b32024-06-07Exact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENBryant Ranch Prepack74134b90-d4c7-41bd-a1bd-2ac168db596f2024-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENAdvanced Rx Pharmacy of Tennessee, LLC1431b769-5535-78d6-e063-6394a90a84232024-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENAsclemed USA, Inc.5a48c0d4-37bf-4c26-a9a7-5c67ff2adb4b2024-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198013
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENMedsource Pharmaceuticals12648efc-3be8-a915-e063-6394a90a36202024-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENBryant Ranch Prepack1cdcaba5-5550-40f6-94cc-b0a98cc17d3c2024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENBryant Ranch Prepackd564f52d-171c-4e7d-974c-3a0e192e6c122024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENA-S Medication Solutionsf91c1a6b-b256-42e1-9da0-5f1975dec6ce2023-12-27Boxed 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.