FDA.reportPublic FDA data

naproxen sodium

Product NDC
59779-914
11-digit product format
597790914
Labeler code
59779
Product ID
59779-914_4efc4879-cae3-4f61-b205-32b62f006a66
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA074661
Marketing category
ANDA
Marketing start
2015-07-22
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
59779-914-47naproxen sodium1 in 1 CARTONTABLET, FILM COATED111
59779-914-47naproxen sodium150 in 1 BOTTLETABLET, FILM COATED15011
59779-914-62naproxen sodium24 in 1 BOTTLETABLET, FILM COATED2411
59779-914-62naproxen sodium1 in 1 CARTONTABLET, FILM COATED111
59779-914-68naproxen sodium1 in 1 CARTONTABLET, FILM COATED111
59779-914-68naproxen sodium36 in 1 BOTTLETABLET, FILM COATED3611
59779-914-71naproxen sodium1 in 1 CARTONTABLET, FILM COATED111
59779-914-71naproxen sodium50 in 1 BOTTLETABLET, FILM COATED5011
59779-914-75naproxen sodium90 in 1 BOTTLETABLET, FILM COATED9011
59779-914-76naproxen sodium120 in 1 BOTTLETABLET, FILM COATED12011
59779-914-76naproxen sodium1 in 1 CARTONTABLET, FILM COATED111
59779-914-78naproxen sodium1 in 1 CARTONTABLET, FILM COATED111
59779-914-78naproxen sodium100 in 1 BOTTLETABLET, FILM COATED10011
59779-914-90naproxen sodium500 in 1 BOTTLETABLET, FILM COATED50011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-914-71EA - Each59779-914a78498d7-4a9b-428b-a0d8-67ae477dfdbb12018-10-11
59779-914-78EA - Each59779-91412306f7f-0c75-4c9f-a5ac-f63c70dbab0c12018-10-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN SODIUM TABLET, FILM COATED [CVS PHARMACY]2
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN SODIUM TABLET, FILM COATED [CVS PHARMACY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNAPROXEN SODIUM TABLET, FILM COATED [CVS PHARMACY]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONAPROXEN SODIUM TABLET, FILM COATED [CVS PHARMACY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN SODIUM TABLET, FILM COATED [CVS PHARMACY]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANAPROXEN SODIUM TABLET, FILM COATED [CVS PHARMACY]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ENAPROXEN SODIUM TABLET, FILM COATED [CVS PHARMACY]2
TALCINACTIVE INGREDIENT7SEV7J4R1UNAPROXEN SODIUM TABLET, FILM COATED [CVS PHARMACY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAPROXEN SODIUM TABLET, FILM COATED [CVS PHARMACY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-914NAPROXEN SODIUM TABLET, FILM COATED [CVS PHARMACY]11Current NDC, Legacy NDC, 14 package rows20231114_f246ff56-23e4-4d39-9d73-7c0dd2b99fd3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSNf246ff56-23e4-4d39-9d73-7c0dd2b99fd311
849574naproxen sodium 220 MG Oral TabletSCDf246ff56-23e4-4d39-9d73-7c0dd2b99fd311
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSYf246ff56-23e4-4d39-9d73-7c0dd2b99fd311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-914-47597790914471 in 1 CARTONHistorical
59779-914-625977909146224 in 1 BOTTLEHistorical
59779-914-68597790914681 in 1 CARTONHistorical
59779-914-71597790914711 in 1 CARTONHistorical
59779-914-755977909147590 TABLET, FILM COATED in 1 BOTTLE (59779-914-75) 2022-03-070000-00-00NoNoCurrent
59779-914-7659779091476120 in 1 BOTTLEHistorical
59779-914-78597790914781 BOTTLE in 1 CARTON (59779-914-78) > 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2015-07-220000-00-00NoNoCurrent
59779-914-9059779091490500 in 1 BOTTLEHistorical