FDA.reportPublic FDA data

Naproxen

Product NDC
50090-0478
11-digit product format
500900478
Labeler code
50090
Product ID
50090-0478_ed0c4008-9837-460e-935c-34b7e82fce82
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075927
Marketing category
ANDA
Marketing start
2010-02-18
Marketing end
0000-00-00
Substance
NAPROXEN
Active strength
500 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
2022-12-31
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
50090-0478-02023-01-30C16284748780-1f386c64a-36d5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
50090-0478-12023-01-30C16284748780-1f386c64a-36d5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
50090-0478-22023-01-30C16284748780-1f386c64a-36d5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
50090-0478-42023-01-30C16284748780-1f386c64a-36d5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
50090-0478-62023-01-30C16284748780-1f386c64a-36d5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
50090-0478-72023-01-30C16284748780-1f386c64a-36d5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0478-0Naproxen15 in 1 BOTTLETABLET1534
50090-0478-1Naproxen20 in 1 BOTTLETABLET2034
50090-0478-2Naproxen30 in 1 BOTTLETABLET3034
50090-0478-4Naproxen14 in 1 BOTTLETABLET1434
50090-0478-6Naproxen100 in 1 BOTTLETABLET10034
50090-0478-7Naproxen60 in 1 BOTTLETABLET6034

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0478-0EA - Each50090-0478acc1eb72-d9dd-4d8c-a1e7-a51bb9e3b90912018-09-05
50090-0478-1EA - Each50090-04782a685a8f-4c9f-4437-b98c-5344ee7ea47712018-10-11
50090-0478-2EA - Each50090-04782d2f4da7-0152-4b85-9802-2b4007f9943c12018-10-11
50090-0478-4EA - Each50090-047864b98412-738d-4d9a-8839-7f19aabf122412018-10-11
50090-0478-6EA - Each50090-04782d0d4009-2543-42e1-a0ef-87076886715e12018-10-11
50090-0478-7EA - Each50090-04786b50e1c5-0148-4e2c-ab2b-98c0b2bf7dae12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0478NAPROXEN TABLET [A-S MEDICATION SOLUTIONS]34Legacy NDC, 6 package rows20210611_53865075-2d8d-4390-b392-5645cfd90e7b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198013naproxen 250 MG Oral TabletPSN53865075-2d8d-4390-b392-5645cfd90e7b34
198012naproxen 375 MG Oral TabletPSN53865075-2d8d-4390-b392-5645cfd90e7b34
198014naproxen 500 MG Oral TabletPSN53865075-2d8d-4390-b392-5645cfd90e7b34
198013naproxen 250 MG Oral TabletSCD53865075-2d8d-4390-b392-5645cfd90e7b34
198012naproxen 375 MG Oral TabletSCD53865075-2d8d-4390-b392-5645cfd90e7b34
198014naproxen 500 MG Oral TabletSCD53865075-2d8d-4390-b392-5645cfd90e7b34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0478-05009004780015 TABLET in 1 BOTTLE (50090-0478-0) 15 tablet2014-11-280000-00-00NoNoCurrent
50090-0478-15009004780120 TABLET in 1 BOTTLE (50090-0478-1) 20 tablet2014-11-280000-00-00NoNoCurrent
50090-0478-25009004780230 TABLET in 1 BOTTLE (50090-0478-2) 30 tablet2014-11-280000-00-00NoNoCurrent
50090-0478-45009004780414 TABLET in 1 BOTTLE (50090-0478-4) 14 tablet2014-11-280000-00-00NoNoCurrent
50090-0478-650090047806100 TABLET in 1 BOTTLE (50090-0478-6) 100 tablet2014-11-280000-00-00NoNoCurrent
50090-0478-75009004780760 TABLET in 1 BOTTLE (50090-0478-7) 60 tablet2014-11-280000-00-00NoNoCurrent