FDA.reportPublic FDA data

Naproxen

Product NDC
51655-626
11-digit product format
516550626
Labeler code
51655
Product ID
51655-626_c4dec1eb-a9db-4594-ab43-3ced16738fde
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Pharmaceuticals
Application
ANDA078250
Marketing category
ANDA
Marketing start
2014-05-28
Marketing end
0000-00-00
Substance
NAPROXEN
Active strength
500 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-626-202024-07-24C16284748780-19d75b9d1-08d6-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS. NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS for oral use Initial U.S. Approval: 1976
51655-626-252024-07-24C16284748780-19d75b9d1-08d6-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS. NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS for oral use Initial U.S. Approval: 1976
51655-626-522024-07-24C16284748780-19d75b9d1-08d6-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS. NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS for oral use Initial U.S. Approval: 1976
51655-626-832024-07-24C16284748780-19d75b9d1-08d6-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS. NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS for oral use Initial U.S. Approval: 1976
51655-626-202020-01-31C16284748780-19d75b9d1-08d6-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS. NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS for oral use Initial U.S. Approval: 1976
51655-626-252020-01-31C16284748780-19d75b9d1-08d6-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS. NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS for oral use Initial U.S. Approval: 1976
51655-626-522020-01-31C16284748780-19d75b9d1-08d6-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS. NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS for oral use Initial U.S. Approval: 1976
51655-626-832020-01-31C16284748780-19d75b9d1-08d6-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS. NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS for oral use Initial U.S. Approval: 1976

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-626-20Naproxen20 in 1 BOTTLE, DISPENSINGTABLET205
51655-626-25Naproxen60 in 1 BOTTLE, DISPENSINGTABLET605
51655-626-26Naproxen90 in 1 BOTTLE, PLASTICTABLET905
51655-626-52Naproxen30 in 1 BOTTLE, DISPENSINGTABLET305
51655-626-83Naproxen180 in 1 BOTTLE, DISPENSINGTABLET1805

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [NORTHWIND PHARMACEUTICALS]4
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [NORTHWIND PHARMACEUTICALS]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-626NAPROXEN TABLET [NORTHWIND PHARMACEUTICALS, LLC]5Legacy NDC, 5 package rows20240724_d90378ef-c513-4471-a132-49720ac5d3a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSNd90378ef-c513-4471-a132-49720ac5d3a35
198014naproxen 500 MG Oral TabletSCDd90378ef-c513-4471-a132-49720ac5d3a35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
51655-626-205165506262020 in 1 BOTTLE, DISPENSINGHistorical
51655-626-255165506262560 in 1 BOTTLE, DISPENSINGHistorical
51655-626-265165506262690 in 1 BOTTLE, PLASTICHistorical
51655-626-525165506265230 in 1 BOTTLE, DISPENSINGHistorical
51655-626-8351655062683180 in 1 BOTTLE, DISPENSINGHistorical