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
Label	Manufacturer	Effective date	Type
Naproxen - Advanced Rx of Tennessee, LLC	Advanced Rx of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80425-0010-1	Naproxen	60 in 1 BOTTLE	TABLET	60		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0010	NAPROXEN TABLET [ADVANCED RX OF TENNESSEE, LLC]	5	Current NDC, Legacy NDC, 1 package rows	20250101_af9ad850-57b5-a21d-e053-2a95a90ae68e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0010-1	EA - Each	80425-0010	2f16bf83-1509-4482-98a0-e46304552dfb	1	2023-06-06

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 8 of 8 · 144 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen	NAPROXEN	Cipla USA Inc.	e06c2b43-9882-442e-8413-10d9a33aecb9	2019-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 57Y76R9ATQ
NAPROXEN	NAPROXEN	TIME CAP LABORATORIES	4350a2d9-5228-460e-b7b1-27e8fa846787	2018-10-09	Warnings	Exact identifier rxcui: 198014 rxcui: 198013 rxcui: 198012 unii: 57Y76R9ATQ
Naproxen	NAPROXEN	Aphena Pharma Solutions - Tennessee, LLC	e2347581-90da-429a-b17c-cffd0039fb86	2017-10-23	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 198014 rxcui: 198013 rxcui: 198012 unii: 57Y76R9ATQ
Naproxen	NAPROXEN	NCS HealthCare of KY, Inc dba Vangard Labs	62a12771-bde9-4bc3-9ce9-672c8e31f020	2017-10-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA075927 rxcui: 198014 unii: 57Y76R9ATQ

Reported adverse events (FAERS/openFDA)#

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