FDA.reportPublic FDA data

CareOne Naproxen Sodium

Product NDC
41520-507
11-digit product format
415200507
Labeler code
41520
Product ID
41520-507_b1921833-7307-4f20-84bb-d63dab25a76c
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Sales Company
Application
ANDA074661
Marketing category
ANDA
Marketing start
2016-08-05
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
CareOne 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
41520-507-48CareOne Naproxen Sodium90 in 1 BOTTLETABLET, FILM COATED908
41520-507-48CareOne Naproxen Sodium2 in 1 CARTONTABLET, FILM COATED28
41520-507-71CareOne Naproxen Sodium50 in 1 BOTTLETABLET, FILM COATED508
41520-507-71CareOne Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED18
41520-507-72CareOne Naproxen Sodium60 in 1 BOTTLETABLET, FILM COATED608
41520-507-72CareOne Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED18
41520-507-75CareOne Naproxen Sodium90 in 1 BOTTLETABLET, FILM COATED908
41520-507-75CareOne Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED18
41520-507-78CareOne Naproxen Sodium100 in 1 BOTTLETABLET, FILM COATED1008
41520-507-78CareOne Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED18
41520-507-82CareOne Naproxen Sodium100 in 1 BOTTLETABLET, FILM COATED1008
41520-507-82CareOne Naproxen Sodium2 in 1 CARTONTABLET, FILM COATED28
41520-507-87CareOne Naproxen Sodium300 in 1 BOTTLETABLET, FILM COATED3008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-507CAREONE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [AMERICAN SALES COMPANY]8Current NDC, Legacy NDC, 13 package rows20250308_0ac4c343-a5b6-4f69-a75a-87074dc867e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN0ac4c343-a5b6-4f69-a75a-87074dc867e88
849574naproxen sodium 220 MG Oral TabletSCD0ac4c343-a5b6-4f69-a75a-87074dc867e88
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY0ac4c343-a5b6-4f69-a75a-87074dc867e88

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-507-48415200507482 BOTTLE in 1 CARTON (41520-507-48) > 90 TABLET, FILM COATED in 1 BOTTLE2 bottle2022-02-250000-00-00NoNoCurrent
41520-507-71415200507711 BOTTLE in 1 CARTON (41520-507-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-08-050000-00-00NoNoCurrent
41520-507-72415200507721 BOTTLE in 1 CARTON (41520-507-72) > 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-08-050000-00-00NoNoCurrent
41520-507-75415200507751 BOTTLE in 1 CARTON (41520-507-75) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-02-250000-00-00NoNoCurrent
41520-507-78415200507781 BOTTLE in 1 CARTON (41520-507-78) > 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-08-050000-00-00NoNoCurrent
41520-507-82415200507822 BOTTLE in 1 CARTON (41520-507-82) > 100 TABLET, FILM COATED in 1 BOTTLE2 bottle2016-08-050000-00-00NoNoCurrent
41520-507-8741520050787300 TABLET, FILM COATED in 1 BOTTLE (41520-507-87) 2018-05-250000-00-00NoNoCurrent