FDA.reportPublic FDA data

Naproxen

Product NDC
53002-3241
11-digit product format
530023241
Labeler code
53002
Product ID
53002-3241_984d2f71-6047-4826-905f-7545f33a3711
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
250 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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
53002-3241-22025-01-30C16284748780-12cef2736-7292-d83d-e063-dadaa90ab31fThese 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
53002-3241-32025-01-30C16284748780-12cef2736-7292-d83d-e063-dadaa90ab31fThese 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
53002-3241-2Naproxen20 in 1 BOTTLETABLET204
53002-3241-3Naproxen30 in 1 BOTTLETABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-3241NAPROXEN TABLET [RPK PHARMACEUTICALS, INC.]4Legacy NDC, 2 package rows20220331_8066fff6-a9ba-4a94-9412-7f8ef8c028e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198013naproxen 250 MG Oral TabletPSN8066fff6-a9ba-4a94-9412-7f8ef8c028e24
198013naproxen 250 MG Oral TabletSCD8066fff6-a9ba-4a94-9412-7f8ef8c028e24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-3241-25300232410220 TABLET in 1 BOTTLE (53002-3241-2) 20 tablet2022-01-010000-00-00NoNoCurrent
53002-3241-35300232410330 TABLET in 1 BOTTLE (53002-3241-3) 30 tablet2022-01-010000-00-00NoNoCurrent