FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
58602-738
11-digit product format
586020738
Labeler code
58602
Product ID
58602-738_3d89b39b-8273-4715-91b1-7a8bccb458d8
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA205497
Marketing category
ANDA
Marketing start
2016-03-18
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 Sodium
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
58602-738-07Naproxen Sodium24 in 1 BOTTLETABLET, FILM COATED249
58602-738-07Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED19
58602-738-12Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED19
58602-738-12Naproxen Sodium40 in 1 BOTTLETABLET, FILM COATED409
58602-738-14Naproxen Sodium50 in 1 BOTTLETABLET, FILM COATED509
58602-738-14Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED19
58602-738-19Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED19
58602-738-19Naproxen Sodium90 in 1 BOTTLETABLET, FILM COATED909
58602-738-21Naproxen Sodium100 in 1 BOTTLETABLET, FILM COATED1009
58602-738-21Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED19
58602-738-25Naproxen Sodium130 in 1 BOTTLETABLET, FILM COATED1309
58602-738-25Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED19
58602-738-29Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED19
58602-738-29Naproxen Sodium150 in 1 BOTTLETABLET, FILM COATED1509
58602-738-34Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED19
58602-738-34Naproxen Sodium200 in 1 BOTTLETABLET, FILM COATED2009
58602-738-38Naproxen Sodium300 in 1 BOTTLETABLET, FILM COATED3009
58602-738-40Naproxen Sodium500 in 1 BOTTLETABLET, FILM COATED5009
58602-738-44Naproxen Sodium400 in 1 BOTTLETABLET, FILM COATED4009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-738NAPROXEN SODIUM TABLET, FILM COATED [AUROHEALTH LLC]9Current NDC, Legacy NDC, 19 package rows20250528_2dfa820c-5130-43b0-9e63-19354bbbd3c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN2dfa820c-5130-43b0-9e63-19354bbbd3c39
849574naproxen sodium 220 MG Oral TabletSCD2dfa820c-5130-43b0-9e63-19354bbbd3c39
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY2dfa820c-5130-43b0-9e63-19354bbbd3c39

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-738-07586020738071 BOTTLE in 1 CARTON (58602-738-07) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-03-180000-00-00NoNoCurrent
58602-738-12586020738121 BOTTLE in 1 CARTON (58602-738-12) / 40 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-03-180000-00-00NoNoCurrent
58602-738-14586020738141 BOTTLE in 1 CARTON (58602-738-14) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-03-180000-00-00NoNoCurrent
58602-738-19586020738191 BOTTLE in 1 CARTON (58602-738-19) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-08-02NoNoCurrent
58602-738-21586020738211 BOTTLE in 1 CARTON (58602-738-21) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-03-180000-00-00NoNoCurrent
58602-738-25586020738251 BOTTLE in 1 CARTON (58602-738-25) / 130 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-03-180000-00-00NoNoCurrent
58602-738-29586020738291 BOTTLE in 1 CARTON (58602-738-29) / 150 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-03-180000-00-00NoNoCurrent
58602-738-34586020738341 BOTTLE in 1 CARTON (58602-738-34) / 200 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-03-180000-00-00NoNoCurrent
58602-738-3858602073838300 TABLET, FILM COATED in 1 BOTTLE (58602-738-38) 2016-03-180000-00-00NoNoCurrent
58602-738-4058602073840500 TABLET, FILM COATED in 1 BOTTLE (58602-738-40) 2016-03-180000-00-00NoNoCurrent
58602-738-4458602073844400 TABLET, FILM COATED in 1 BOTTLE (58602-738-44) 2016-03-180000-00-00NoNoCurrent