NAPROXEN

Product NDC
52605-139
11-digit product format
526050139
Labeler code
52605
Product ID
52605-139_d349356e-61d3-4728-8425-1a4d513605d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NAPROXEN
Dosage form
TABLET
Route
ORAL
Labeler
Polygen Pharmaceuticals LLC
Application
ANDA091416
Marketing category
ANDA
Marketing start
2012-02-01
Marketing end
0000-00-00
Substance
NAPROXEN
Active strength
375 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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
52605-139-012020-01-31C16284748780-19d75b9d0-6a39-f424-e053-dadaa90a57ceNaproxen Tablets, USP 250mg, 375mg, 500 mg
52605-139-052020-01-31C16284748780-19d75b9d0-6a39-f424-e053-dadaa90a57ceNaproxen Tablets, USP 250mg, 375mg, 500 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52605-139-01NAPROXEN100 in 1 BOTTLETABLET1006
52605-139-05NAPROXEN500 in 1 BOTTLETABLET5006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52605-139NAPROXEN TABLET [POLYGEN PHARMACEUTICALS LLC]6Legacy NDC, 2 package rows20130628_2e84d479-5536-471f-93ef-34c353aff071.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198013naproxen 250 MG Oral TabletPSN2e84d479-5536-471f-93ef-34c353aff0716
198012naproxen 375 MG Oral TabletPSN2e84d479-5536-471f-93ef-34c353aff0716
198014naproxen 500 MG Oral TabletPSN2e84d479-5536-471f-93ef-34c353aff0716
198013naproxen 250 MG Oral TabletSCD2e84d479-5536-471f-93ef-34c353aff0716
198012naproxen 375 MG Oral TabletSCD2e84d479-5536-471f-93ef-34c353aff0716
198014naproxen 500 MG Oral TabletSCD2e84d479-5536-471f-93ef-34c353aff0716

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52605-139-0152605013901100 in 1 BOTTLEHistorical
52605-139-0552605013905500 in 1 BOTTLEHistorical