FDA.reportPublic FDA data

Naproxen

Product NDC
71610-560
11-digit product format
716100560
Labeler code
71610
Product ID
71610-560_2600a32b-91fd-40f4-9f0a-405db423878f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA212517
Marketing category
ANDA
Marketing start
2020-03-01
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
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
71610-560-532023-01-30C16284748780-1f386c64a-384b-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
71610-560-602023-01-30C16284748780-1f386c64a-384b-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
71610-560-802023-01-30C16284748780-1f386c64a-384b-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
71610-560-53Naproxen60 in 1 BOTTLETABLET601
71610-560-60Naproxen90 in 1 BOTTLETABLET901
71610-560-80Naproxen180 in 1 BOTTLETABLET1801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-560NAPROXEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 3 package rows20210626_39d34c1a-d1a8-434c-9f89-eed52e764fa6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSN39d34c1a-d1a8-434c-9f89-eed52e764fa61
198014naproxen 500 MG Oral TabletSCD39d34c1a-d1a8-434c-9f89-eed52e764fa61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-560-537161005605360 TABLET in 1 BOTTLE (71610-560-53) 60 tablet2021-05-250000-00-00NoNoCurrent
71610-560-607161005606090 TABLET in 1 BOTTLE (71610-560-60) 90 tablet2021-05-250000-00-00NoNoCurrent
71610-560-8071610056080180 TABLET in 1 BOTTLE (71610-560-80) 180 tablet2021-05-250000-00-00NoNoCurrent