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 5 of 8 · 144 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NaproxenNAPROXENBryant Ranch Prepack9d7bc470-fbba-40a6-a56c-f681a3cee9cf2025-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075927
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENPreferred Pharmaceuticals Inc.727913f6-9542-4a2d-9318-4b7ff521bffd2025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENAmneal Pharmaceuticals of New York LLC2718e0b7-1ce6-457e-bee9-11b634dfd3532025-03-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075927
rxcui: 198014
rxcui: 198013
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENANI Pharmaceuticals, Inc.052e6fe3-d619-42c3-b64e-67c7aaf7271c2025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMScieGen Pharmaceuticals, Inc167340c2-1234-4d00-b4e2-cccf3d270fda2025-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMBryant Ranch Prepack3f1c66f0-2d9d-4be1-8656-1dbed2c9c7152025-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENDirect_Rxf499a207-02c8-a338-e053-2995a90accc02025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
unii: 57Y76R9ATQ
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMBryant Ranch Prepackf3a3eea2-f6b3-4559-8536-26c1125df3e12025-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NAPROXENNAPROXENDIRECT RXb1b78c49-82e9-2402-e053-2a95a90ae35f2025-01-17WarningsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMBryant Ranch Prepack19aadd4b-647b-4c75-9059-9a2c68a185612025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENAdvanced Rx of Tennessee, LLCaf9ad850-57b5-a21d-e053-2a95a90ae68e2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075927
ndc (package): 80425-0010-1
ndc (product): 80425-0010
ndc11 (package): 80425001001
rxcui: 198012
spl id: 2a982dd7-c530-0a5b-e063-6294a90aafd3
spl set id: af9ad850-57b5-a21d-e053-2a95a90ae68e
unii: 57Y76R9ATQ
NaproxenNAPROXENAdvanced Rx of Tennessee, LLCaf9a94a8-3825-eabd-e053-2a95a90acd582024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075927
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENAdvanced Rx of Tennessee, LLCaf9a96cf-1cda-8ace-e053-2a95a90a18cc2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENAdvanced Rx of Tennessee, LLCaf9ac948-4405-5abf-e053-2995a90af2b52024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENAdvanced Rx of Tennessee, LLCaf9aa7a0-e287-5935-e053-2995a90a1d112024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENAdvanced Rx Pharmacy of Tennessee, LLCd292f376-1844-b01c-e053-2a95a90a09272024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
unii: 57Y76R9ATQ
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMAsclemed USA, Inc.7b3af5a8-0c92-43f4-af13-7a47dca20e922024-12-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMDr. Reddy's Laboratories Limited1ef3fe94-9bbb-934d-a09b-d19a1d23a4d52024-12-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENQuality Care Products, LLC1acfb8cc-6faf-4b3e-9304-4819c42de0a62024-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENHikma Pharmaceuticals USA Inc.a5757b1a-62c9-4421-9794-6fb121ce9b7e2024-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ

Reported adverse events (FAERS/openFDA)#

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