NAPROXEN

Product NDC
53002-3110
11-digit product format
530023110
Labeler code
53002
Product ID
53002-3110_8b7d80ec-40e6-448c-b8af-31a0d433385f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NAPROXEN
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA091416
Marketing category
ANDA
Marketing start
2016-07-06
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
53002-3110-12025-01-30C16284748780-19d75b9d0-42d3-f424-e053-dadaa90a57ce0a9f2151-9436-4a79-877f-c965547eac40
53002-3110-22025-01-30C16284748780-19d75b9d0-42d3-f424-e053-dadaa90a57ce0a9f2151-9436-4a79-877f-c965547eac40
53002-3110-32025-01-30C16284748780-19d75b9d0-42d3-f424-e053-dadaa90a57ce0a9f2151-9436-4a79-877f-c965547eac40
53002-3110-42025-01-30C16284748780-19d75b9d0-42d3-f424-e053-dadaa90a57ce0a9f2151-9436-4a79-877f-c965547eac40
53002-3110-52025-01-30C16284748780-19d75b9d0-42d3-f424-e053-dadaa90a57ce0a9f2151-9436-4a79-877f-c965547eac40
53002-3110-62025-01-30C16284748780-19d75b9d0-42d3-f424-e053-dadaa90a57ce0a9f2151-9436-4a79-877f-c965547eac40
53002-3110-12023-06-07C16284748780-19d75b9d0-42d3-f424-e053-dadaa90a57ce0a9f2151-9436-4a79-877f-c965547eac40
53002-3110-22023-06-07C16284748780-19d75b9d0-42d3-f424-e053-dadaa90a57ce0a9f2151-9436-4a79-877f-c965547eac40
53002-3110-32023-06-07C16284748780-19d75b9d0-42d3-f424-e053-dadaa90a57ce0a9f2151-9436-4a79-877f-c965547eac40
53002-3110-42023-06-07C16284748780-19d75b9d0-42d3-f424-e053-dadaa90a57ce0a9f2151-9436-4a79-877f-c965547eac40
53002-3110-52023-06-07C16284748780-19d75b9d0-42d3-f424-e053-dadaa90a57ce0a9f2151-9436-4a79-877f-c965547eac40
53002-3110-62023-06-07C16284748780-19d75b9d0-42d3-f424-e053-dadaa90a57ce0a9f2151-9436-4a79-877f-c965547eac40
53002-3110-12023-01-30C16284748780-19d75b9d0-42d3-f424-e053-dadaa90a57ce0a9f2151-9436-4a79-877f-c965547eac40
53002-3110-22023-01-30C16284748780-19d75b9d0-42d3-f424-e053-dadaa90a57ce0a9f2151-9436-4a79-877f-c965547eac40
53002-3110-32023-01-30C16284748780-19d75b9d0-42d3-f424-e053-dadaa90a57ce0a9f2151-9436-4a79-877f-c965547eac40
53002-3110-42023-01-30C16284748780-19d75b9d0-42d3-f424-e053-dadaa90a57ce0a9f2151-9436-4a79-877f-c965547eac40
53002-3110-52023-01-30C16284748780-19d75b9d0-42d3-f424-e053-dadaa90a57ce0a9f2151-9436-4a79-877f-c965547eac40
53002-3110-62023-01-30C16284748780-19d75b9d0-42d3-f424-e053-dadaa90a57ce0a9f2151-9436-4a79-877f-c965547eac40
53002-3110-12020-12-15C16284748780-19d75b9d0-42d3-f424-e053-dadaa90a57ce0a9f2151-9436-4a79-877f-c965547eac40
53002-3110-22020-12-15C16284748780-19d75b9d0-42d3-f424-e053-dadaa90a57ce0a9f2151-9436-4a79-877f-c965547eac40
53002-3110-32020-12-15C16284748780-19d75b9d0-42d3-f424-e053-dadaa90a57ce0a9f2151-9436-4a79-877f-c965547eac40
53002-3110-42020-12-15C16284748780-19d75b9d0-42d3-f424-e053-dadaa90a57ce0a9f2151-9436-4a79-877f-c965547eac40
53002-3110-52020-12-15C16284748780-19d75b9d0-42d3-f424-e053-dadaa90a57ce0a9f2151-9436-4a79-877f-c965547eac40
53002-3110-62020-12-15C16284748780-19d75b9d0-42d3-f424-e053-dadaa90a57ce0a9f2151-9436-4a79-877f-c965547eac40
53002-3110-12020-01-31C16284748780-19d75b9d0-42d3-f424-e053-dadaa90a57ce0a9f2151-9436-4a79-877f-c965547eac40
53002-3110-22020-01-31C16284748780-19d75b9d0-42d3-f424-e053-dadaa90a57ce0a9f2151-9436-4a79-877f-c965547eac40
53002-3110-32020-01-31C16284748780-19d75b9d0-42d3-f424-e053-dadaa90a57ce0a9f2151-9436-4a79-877f-c965547eac40
53002-3110-42020-01-31C16284748780-19d75b9d0-42d3-f424-e053-dadaa90a57ce0a9f2151-9436-4a79-877f-c965547eac40
53002-3110-52020-01-31C16284748780-19d75b9d0-42d3-f424-e053-dadaa90a57ce0a9f2151-9436-4a79-877f-c965547eac40
53002-3110-62020-01-31C16284748780-19d75b9d0-42d3-f424-e053-dadaa90a57ce0a9f2151-9436-4a79-877f-c965547eac40

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-3110-1NAPROXEN10 in 1 BOTTLETABLET105
53002-3110-2NAPROXEN14 in 1 BOTTLETABLET145
53002-3110-3NAPROXEN15 in 1 BOTTLETABLET155
53002-3110-4NAPROXEN20 in 1 BOTTLETABLET205
53002-3110-5NAPROXEN30 in 1 BOTTLETABLET305
53002-3110-6NAPROXEN60 in 1 BOTTLETABLET605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-3110NAPROXEN TABLET [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 6 package rows20230609_0a9f2151-9436-4a79-877f-c965547eac40.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSN0a9f2151-9436-4a79-877f-c965547eac405
198014naproxen 500 MG Oral TabletSCD0a9f2151-9436-4a79-877f-c965547eac405

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-3110-15300231100110 TABLET in 1 BOTTLE (53002-3110-1) 10 tablet2017-10-010000-00-00NoNoCurrent
53002-3110-25300231100214 TABLET in 1 BOTTLE (53002-3110-2) 14 tablet2017-10-010000-00-00NoNoCurrent
53002-3110-35300231100315 TABLET in 1 BOTTLE (53002-3110-3) 15 tablet2017-10-010000-00-00NoNoCurrent
53002-3110-45300231100420 TABLET in 1 BOTTLE (53002-3110-4) 20 tablet2017-10-010000-00-00NoNoCurrent
53002-3110-55300231100530 TABLET in 1 BOTTLE (53002-3110-5) 30 tablet2017-10-010000-00-00NoNoCurrent
53002-3110-65300231100660 TABLET in 1 BOTTLE (53002-3110-6) 60 tablet2017-10-010000-00-00NoNoCurrent