NAPROXEN

Product NDC
69150-139
11-digit product format
691500139
Labeler code
69150
Product ID
69150-139_b91b8834-9d71-4a53-ac54-762da3d5c578
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NAPROXEN
Dosage form
TABLET
Route
ORAL
Labeler
Biomes Pharmaceuticals
Application
ANDA091416
Marketing category
ANDA
Marketing start
2015-03-23
Marketing end
0000-00-00
Substance
NAPROXEN
Active strength
375 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
69150-139-142020-01-31C16284748780-19d75b9d0-997f-f424-e053-dadaa90a57ceNaproxen - 138, 139, 140
69150-139-152020-01-31C16284748780-19d75b9d0-997f-f424-e053-dadaa90a57ceNaproxen - 138, 139, 140
69150-139-162020-01-31C16284748780-19d75b9d0-997f-f424-e053-dadaa90a57ceNaproxen - 138, 139, 140

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69150-139-14NAPROXEN1000 in 1 BOTTLETABLET10004
69150-139-15NAPROXEN500 in 1 BOTTLETABLET5004
69150-139-16NAPROXEN100 in 1 BOTTLETABLET1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69150-139NAPROXEN TABLET [BIOMES PHARMACEUTICALS]4Legacy NDC, 3 package rows20160620_80217f60-9b41-911a-2bee-aa7de615c9d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198013naproxen 250 MG Oral TabletPSN80217f60-9b41-911a-2bee-aa7de615c9d14
198012naproxen 375 MG Oral TabletPSN80217f60-9b41-911a-2bee-aa7de615c9d14
198014naproxen 500 MG Oral TabletPSN80217f60-9b41-911a-2bee-aa7de615c9d14
198013naproxen 250 MG Oral TabletSCD80217f60-9b41-911a-2bee-aa7de615c9d14
198012naproxen 375 MG Oral TabletSCD80217f60-9b41-911a-2bee-aa7de615c9d14
198014naproxen 500 MG Oral TabletSCD80217f60-9b41-911a-2bee-aa7de615c9d14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69150-139-14691500139141000 in 1 BOTTLEHistorical
69150-139-1569150013915500 in 1 BOTTLEHistorical
69150-139-1669150013916100 in 1 BOTTLEHistorical