FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
63187-596
11-digit product format
631870596
Labeler code
63187
Product ID
63187-596_056f2617-2de4-4296-bd4d-714f34f7a15c
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA074661
Marketing category
ANDA
Marketing start
2014-04-11
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
63187-596-24Naproxen Sodium24 in 1 BOTTLETABLET, FILM COATED246
63187-596-28Naproxen Sodium28 in 1 BOTTLETABLET, FILM COATED286
63187-596-30Naproxen Sodium30 in 1 BOTTLETABLET, FILM COATED306
63187-596-60Naproxen Sodium90 in 1 BOTTLETABLET, FILM COATED906
63187-596-90Naproxen Sodium60 in 1 BOTTLETABLET, FILM COATED606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-596NAPROXEN SODIUM TABLET, FILM COATED [PROFICIENT RX LP]6Current NDC, Legacy NDC, 5 package rows20220514_e668c80f-dd53-4b82-8678-5e4fccb13023.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSNe668c80f-dd53-4b82-8678-5e4fccb130236
849574naproxen sodium 220 MG Oral TabletSCDe668c80f-dd53-4b82-8678-5e4fccb130236
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSYe668c80f-dd53-4b82-8678-5e4fccb130236

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-596-246318705962424 TABLET, FILM COATED in 1 BOTTLE (63187-596-24) 2017-09-010000-00-00NoNoCurrent
63187-596-286318705962828 TABLET, FILM COATED in 1 BOTTLE (63187-596-28) 2017-08-010000-00-00NoNoCurrent
63187-596-306318705963030 TABLET, FILM COATED in 1 BOTTLE (63187-596-30) 2015-08-030000-00-00NoNoCurrent
63187-596-606318705966090 TABLET, FILM COATED in 1 BOTTLE (63187-596-60) 2015-08-030000-00-00NoNoCurrent
63187-596-906318705969060 TABLET, FILM COATED in 1 BOTTLE (63187-596-90) 2015-08-030000-00-00NoNoCurrent