FDA.reportPublic FDA data

Naproxen

Product NDC
53002-3111
11-digit product format
530023111
Labeler code
53002
Product ID
53002-3111_dc2139a9-b813-4916-b71a-29561e3f7bcc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA078250
Marketing category
ANDA
Marketing start
2007-07-01
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
2021-12-31
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
53002-3111-12025-01-30C16284748780-19d75b9d0-1d38-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM 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
53002-3111-22025-01-30C16284748780-19d75b9d0-1d38-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM 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
53002-3111-42025-01-30C16284748780-19d75b9d0-1d38-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM 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
53002-3111-52025-01-30C16284748780-19d75b9d0-1d38-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM 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
53002-3111-62025-01-30C16284748780-19d75b9d0-1d38-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM 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
53002-3111-12023-06-07C16284748780-19d75b9d0-1d38-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM 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
53002-3111-22023-06-07C16284748780-19d75b9d0-1d38-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM 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
53002-3111-42023-06-07C16284748780-19d75b9d0-1d38-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM 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
53002-3111-52023-06-07C16284748780-19d75b9d0-1d38-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM 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
53002-3111-62023-06-07C16284748780-19d75b9d0-1d38-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM 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
53002-3111-12023-01-30C16284748780-19d75b9d0-1d38-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM 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
53002-3111-22023-01-30C16284748780-19d75b9d0-1d38-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM 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
53002-3111-42023-01-30C16284748780-19d75b9d0-1d38-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM 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
53002-3111-52023-01-30C16284748780-19d75b9d0-1d38-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM 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
53002-3111-62023-01-30C16284748780-19d75b9d0-1d38-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM 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
53002-3111-12020-12-16C16284748780-19d75b9d0-1d38-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM 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
53002-3111-22020-12-16C16284748780-19d75b9d0-1d38-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM 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
53002-3111-42020-12-16C16284748780-19d75b9d0-1d38-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM 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
53002-3111-52020-12-16C16284748780-19d75b9d0-1d38-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM 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
53002-3111-62020-12-16C16284748780-19d75b9d0-1d38-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM 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
53002-3111-12020-01-31C16284748780-19d75b9d0-1d38-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM 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
53002-3111-22020-01-31C16284748780-19d75b9d0-1d38-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM 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
53002-3111-42020-01-31C16284748780-19d75b9d0-1d38-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM 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
53002-3111-52020-01-31C16284748780-19d75b9d0-1d38-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM 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
53002-3111-62020-01-31C16284748780-19d75b9d0-1d38-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM 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
53002-3111-1Naproxen10 in 1 BOTTLETABLET105
53002-3111-2Naproxen14 in 1 BOTTLETABLET145
53002-3111-4Naproxen20 in 1 BOTTLETABLET205
53002-3111-5Naproxen30 in 1 BOTTLETABLET305
53002-3111-6Naproxen60 in 1 BOTTLETABLET605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-3111NAPROXEN TABLET [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 5 package rows20230609_9f13f187-ed93-468a-92fb-1059dd409e57.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSN9f13f187-ed93-468a-92fb-1059dd409e575
198014naproxen 500 MG Oral TabletSCD9f13f187-ed93-468a-92fb-1059dd409e575

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-3111-15300231110110 TABLET in 1 BOTTLE (53002-3111-1) 10 tablet2018-10-010000-00-00NoNoCurrent
53002-3111-25300231110214 TABLET in 1 BOTTLE (53002-3111-2) 14 tablet2018-10-010000-00-00NoNoCurrent
53002-3111-45300231110420 TABLET in 1 BOTTLE (53002-3111-4) 20 tablet2018-10-010000-00-00NoNoCurrent
53002-3111-55300231110530 TABLET in 1 BOTTLE (53002-3111-5) 30 tablet2018-10-010000-00-00NoNoCurrent
53002-3111-65300231110660 TABLET in 1 BOTTLE (53002-3111-6) 60 tablet2018-10-010000-00-00NoNoCurrent