FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
41250-477
11-digit product format
412500477
Labeler code
41250
Product ID
41250-477_05bd2fec-f777-4753-b864-b3d406fb0678
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Meijer Distribution Inc
Application
ANDA074661
Marketing category
ANDA
Marketing start
2014-03-05
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
41250-477-62Naproxen Sodium24 in 1 BOTTLETABLET, FILM COATED248
41250-477-62Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED18
41250-477-71Naproxen Sodium50 in 1 BOTTLETABLET, FILM COATED508
41250-477-71Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED18
41250-477-75Naproxen Sodium90 in 1 BOTTLETABLET, FILM COATED908
41250-477-75Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED18
41250-477-76Naproxen Sodium120 in 1 BOTTLETABLET, FILM COATED1208
41250-477-76Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED18
41250-477-78Naproxen Sodium100 in 1 BOTTLETABLET, FILM COATED1008
41250-477-78Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED18
41250-477-79Naproxen Sodium400 in 1 BOTTLETABLET, FILM COATED4008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-477NAPROXEN SODIUM TABLET, FILM COATED [MEIJER DISTRIBUTION INC]8Current NDC, Legacy NDC, 11 package rows20250305_9551e84b-19bc-43e7-9c6e-0f24fdeb5abe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN9551e84b-19bc-43e7-9c6e-0f24fdeb5abe8
849574naproxen sodium 220 MG Oral TabletSCD9551e84b-19bc-43e7-9c6e-0f24fdeb5abe8
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY9551e84b-19bc-43e7-9c6e-0f24fdeb5abe8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-477-62412500477621 BOTTLE in 1 CARTON (41250-477-62) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-07-060000-00-00NoNoCurrent
41250-477-71412500477711 BOTTLE in 1 CARTON (41250-477-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2014-03-050000-00-00NoNoCurrent
41250-477-75412500477751 BOTTLE in 1 CARTON (41250-477-75) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-05-260000-00-00NoNoCurrent
41250-477-76412500477761 BOTTLE in 1 CARTON (41250-477-76) > 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2014-03-050000-00-00NoNoCurrent
41250-477-78412500477781 BOTTLE in 1 CARTON (41250-477-78) > 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2014-03-050000-00-00NoNoCurrent
41250-477-7941250047779400 TABLET, FILM COATED in 1 BOTTLE (41250-477-79) 2014-03-050000-00-00NoNoCurrent