FDA.reportPublic FDA data

Naproxen

Product NDC
71205-595
11-digit product format
712050595
Labeler code
71205
Product ID
71205-595_0193d608-f4a8-5a69-e063-6294a90aafe8
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA204872
Marketing category
ANDA
Marketing start
2019-01-01
Substance
NAPROXEN SODIUM
Active strength
220 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
NAPROXEN SODIUM220 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9TN87S3A3C
Rxcui849574

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
71205-595-24Naproxen24 in 1 BOTTLETABLET243
71205-595-30Naproxen30 in 1 BOTTLETABLET303
71205-595-60Naproxen60 in 1 BOTTLETABLET603
71205-595-90Naproxen90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-595-24EA - Each71205-595cf9755fb-f44f-4526-be5b-6d69f368280512023-12-05
71205-595-30EA - Each71205-595b75db615-2644-4c94-8d5d-193dd2cd8b2012021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-595NAPROXEN (NAPROXEN SODIUM) TABLET [PROFICIENT RX LP]3Current NDC, Legacy NDC, 4 package rows20230729_2acd8e24-449d-4f5c-9323-504013ff4bf5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN2acd8e24-449d-4f5c-9323-504013ff4bf53
849574naproxen sodium 220 MG Oral TabletSCD2acd8e24-449d-4f5c-9323-504013ff4bf53
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY2acd8e24-449d-4f5c-9323-504013ff4bf53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-595-247120505952424 TABLET in 1 BOTTLE (71205-595-24) 24 tablet2023-07-28NoNoHistorical
71205-595-307120505953030 TABLET in 1 BOTTLE (71205-595-30) 30 tablet2021-07-270000-00-00NoNoCurrent
71205-595-607120505956060 TABLET in 1 BOTTLE (71205-595-60) 60 tablet2021-07-270000-00-00NoNoCurrent
71205-595-907120505959090 TABLET in 1 BOTTLE (71205-595-90) 90 tablet2021-07-270000-00-00NoNoCurrent