FDA.reportPublic FDA data

Naproxen

Product NDC
71610-597
11-digit product format
716100597
Labeler code
71610
Product ID
71610-597_b86a9e2f-2e2c-4ca7-b3d7-2615e53ae369
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
500 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
NAPROXEN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57Y76R9ATQ
Rxcui198014

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
71610-597-53Naproxen60 in 1 BOTTLETABLET602
71610-597-70Naproxen120 in 1 BOTTLETABLET1202
71610-597-80Naproxen180 in 1 BOTTLETABLET1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-597-53EA - Each71610-597ed8a1765-4816-4f74-9963-b8a1c064a08312022-01-06
71610-597-70EA - Each71610-597de888a3b-02c4-4817-a689-1bfc6a200df212021-11-09
71610-597-80EA - Each71610-597703598f2-f199-41a0-9834-abee33131be612022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-597NAPROXEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 3 package rows20211112_98efdeb8-ea38-456e-953f-ba589727f284.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSN98efdeb8-ea38-456e-953f-ba589727f2842
198014naproxen 500 MG Oral TabletSCD98efdeb8-ea38-456e-953f-ba589727f2842

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-597-537161005975360 TABLET in 1 BOTTLE (71610-597-53) 60 tablet2021-10-260000-00-00NoNoCurrent
71610-597-7071610059770120 TABLET in 1 BOTTLE (71610-597-70) 120 tablet2021-09-090000-00-00NoNoCurrent
71610-597-8071610059780180 TABLET in 1 BOTTLE (71610-597-80) 180 tablet2021-10-260000-00-00NoNoCurrent