FDA.reportPublic FDA data

naproxen

Product NDC
53002-3100
11-digit product format
530023100
Labeler code
53002
Product ID
53002-3100_09c60496-bf1e-406d-8b44-13547628ddd3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
naproxen
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA091305
Marketing category
ANDA
Marketing start
2016-07-05
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
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
53002-3100-12025-01-30C16284748780-19d75b9d0-754f-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. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
53002-3100-22025-01-30C16284748780-19d75b9d0-754f-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. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
53002-3100-32025-01-30C16284748780-19d75b9d0-754f-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. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
53002-3100-42025-01-30C16284748780-19d75b9d0-754f-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. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
53002-3100-12023-06-07C16284748780-19d75b9d0-754f-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. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
53002-3100-22023-06-07C16284748780-19d75b9d0-754f-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. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
53002-3100-32023-06-07C16284748780-19d75b9d0-754f-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. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
53002-3100-42023-06-07C16284748780-19d75b9d0-754f-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. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
53002-3100-12023-01-30C16284748780-19d75b9d0-754f-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. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
53002-3100-22023-01-30C16284748780-19d75b9d0-754f-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. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
53002-3100-32023-01-30C16284748780-19d75b9d0-754f-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. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
53002-3100-42023-01-30C16284748780-19d75b9d0-754f-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. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
53002-3100-12020-12-15C16284748780-19d75b9d0-754f-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. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
53002-3100-22020-12-15C16284748780-19d75b9d0-754f-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. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
53002-3100-32020-12-15C16284748780-19d75b9d0-754f-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. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
53002-3100-42020-12-15C16284748780-19d75b9d0-754f-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. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
53002-3100-12020-01-31C16284748780-19d75b9d0-754f-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. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
53002-3100-22020-01-31C16284748780-19d75b9d0-754f-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. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
53002-3100-32020-01-31C16284748780-19d75b9d0-754f-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. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
53002-3100-42020-01-31C16284748780-19d75b9d0-754f-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. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-3100-1naproxen10 in 1 BOTTLETABLET1013
53002-3100-2naproxen15 in 1 BOTTLETABLET1513
53002-3100-3naproxen20 in 1 BOTTLETABLET2013
53002-3100-4naproxen30 in 1 BOTTLETABLET3013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-3100NAPROXEN TABLET [RPK PHARMACEUTICALS, INC.]13Legacy NDC, 4 package rows20230609_a7f0801c-96de-4d28-b221-627372f2bebd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198013naproxen 250 MG Oral TabletPSNa7f0801c-96de-4d28-b221-627372f2bebd13
198012naproxen 375 MG Oral TabletPSNa7f0801c-96de-4d28-b221-627372f2bebd13
198014naproxen 500 MG Oral TabletPSNa7f0801c-96de-4d28-b221-627372f2bebd13
198013naproxen 250 MG Oral TabletSCDa7f0801c-96de-4d28-b221-627372f2bebd13
198012naproxen 375 MG Oral TabletSCDa7f0801c-96de-4d28-b221-627372f2bebd13
198014naproxen 500 MG Oral TabletSCDa7f0801c-96de-4d28-b221-627372f2bebd13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-3100-15300231000110 TABLET in 1 BOTTLE (53002-3100-1) 10 tablet2018-10-010000-00-00NoNoCurrent
53002-3100-25300231000215 TABLET in 1 BOTTLE (53002-3100-2) 15 tablet2018-10-010000-00-00NoNoCurrent
53002-3100-35300231000320 TABLET in 1 BOTTLE (53002-3100-3) 20 tablet2018-10-010000-00-00NoNoCurrent
53002-3100-45300231000430 TABLET in 1 BOTTLE (53002-3100-4) 30 tablet2018-10-010000-00-00NoNoCurrent