FDA.reportPublic FDA data

Naproxen

Product NDC
80425-0051
11-digit product format
804250051
Labeler code
80425
Product ID
80425-0051_2a98ebb7-ca46-d2dd-e063-6294a90ac15c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA200429
Marketing category
ANDA
Marketing start
2011-11-08
Substance
NAPROXEN
Active strength
500 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Naproxen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57Y76R9ATQ
Rxcui198014

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0051-1Naproxen60 in 1 BOTTLETABLET606
80425-0051-2Naproxen90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0051-1EA - Each80425-005159b6898f-4c1b-4a12-9eab-2ff6aa11451e12023-06-06
80425-0051-2EA - Each80425-00516cf3820b-f7ca-4210-86ee-34a3def6751212023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0051NAPROXEN TABLET [ADVANCED RX OF TENNESSEE, LLC]6Current NDC, Legacy NDC, 2 package rows20250101_af9ac948-4405-5abf-e053-2995a90af2b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSNaf9ac948-4405-5abf-e053-2995a90af2b56
198014naproxen 500 MG Oral TabletSCDaf9ac948-4405-5abf-e053-2995a90af2b56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0051-18042500510160 TABLET in 1 BOTTLE (80425-0051-1) 60 tablet2011-11-080000-00-00NoNoCurrent
80425-0051-28042500510290 TABLET in 1 BOTTLE (80425-0051-2) 90 tablet2011-11-080000-00-00NoNoCurrent