FDA.reportPublic FDA data

Naproxen

Product NDC
71610-592
11-digit product format
716100592
Labeler code
71610
Product ID
71610-592_705546f2-9f9c-4b26-b5a6-f3d32bc92c60
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
2021-06-04
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Naproxen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57Y76R9ATQ
Rxcui198012, 198013

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-592-53Naproxen60 in 1 BOTTLETABLET601
71610-592-80Naproxen180 in 1 BOTTLETABLET1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-592-53EA - Each71610-5927df0247b-7ec7-4f14-8f91-655e6e5a7a0312021-09-07
71610-592-80EA - Each71610-592f297532f-0f03-49e0-9b54-0f2a078c3ef712021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-592NAPROXEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 2 package rows20210822_9c963e77-6e05-47d0-a8d3-e581777377b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198013naproxen 250 MG Oral TabletPSN9c963e77-6e05-47d0-a8d3-e581777377b91
198012naproxen 375 MG Oral TabletPSN9c963e77-6e05-47d0-a8d3-e581777377b91
198013naproxen 250 MG Oral TabletSCD9c963e77-6e05-47d0-a8d3-e581777377b91
198012naproxen 375 MG Oral TabletSCD9c963e77-6e05-47d0-a8d3-e581777377b91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-592-537161005925360 TABLET in 1 BOTTLE (71610-592-53) 60 tablet2021-08-090000-00-00NoNoCurrent
71610-592-8071610059280180 TABLET in 1 BOTTLE (71610-592-80) 180 tablet2021-08-090000-00-00NoNoCurrent