FDA.reportPublic FDA data

Naproxen

Product NDC
70518-3486
11-digit product format
705183486
Labeler code
70518
Product ID
70518-3486_4f1db6b3-e005-8431-e063-6394a90afd63
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA212517
Marketing category
ANDA
Marketing start
2023-08-23
Substance
NAPROXEN
Active strength
375 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Naproxen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN375 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57Y76R9ATQ
Rxcui198012

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
70518-3486-0Naproxen30 in 1 BLISTER PACKTABLET306
70518-3486-1Naproxen60 in 1 BOTTLE, PLASTICTABLET606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3486NAPROXEN TABLET [REMEDYREPACK INC.]3Current NDC, Legacy NDC, 2 package rows20240322_6bb65680-76ea-46e5-ae70-f3091e360368.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198012naproxen 375 MG Oral TabletPSN6bb65680-76ea-46e5-ae70-f3091e3603686
198012naproxen 375 MG Oral TabletSCD6bb65680-76ea-46e5-ae70-f3091e3603686

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3486-07051834860030 TABLET in 1 BLISTER PACK (70518-3486-0) 30 tablet2023-08-230000-00-00NoNoCurrent
70518-3486-17051834860160 TABLET in 1 BOTTLE, PLASTIC (70518-3486-1) 60 tablet2025-07-01NoNoCurrent