FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
25000-141
11-digit product format
250000141
Labeler code
25000
Product ID
25000-141_1e0b6883-f02c-4259-b905-9716dd72bcbf
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium, Coated Tablets
Dosage form
TABLET
Route
ORAL
Labeler
MARKSANS PHARMA LIMITED
Application
ANDA090545
Marketing category
ANDA
Marketing start
2011-05-28
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
25000-141-02Naproxen Sodium1 in 1 CARTONTABLET18
25000-141-02Naproxen Sodium160 in 1 BOXTABLET1608
25000-141-14Naproxen Sodium1000 in 1 BOTTLE, PLASTICTABLET10008
25000-141-26Naproxen Sodium1600 in 1 BAGTABLET16008
25000-141-26Naproxen Sodium2 in 1 BOXTABLET28
25000-141-30Naproxen Sodium6500 in 1 BAGTABLET65008
25000-141-30Naproxen Sodium6 in 1 BOXTABLET68
25000-141-43Naproxen Sodium10 in 1 BOTTLETABLET108
25000-141-98Naproxen Sodium1 in 1 BOXTABLET18
25000-141-98Naproxen Sodium32165 in 1 BAGTABLET321658

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN SODIUM (NAPROXEN SODIUM TABLET, COATED) TABLET NAPROXEN SODIUM (NAPROXEN SODIUM, COATED TABLETS) TABLET [MARKSANS PHARMA LIMITED]3
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN SODIUM (NAPROXEN SODIUM TABLET, COATED) TABLET NAPROXEN SODIUM (NAPROXEN SODIUM, COATED TABLETS) TABLET [MARKSANS PHARMA LIMITED]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNAPROXEN SODIUM (NAPROXEN SODIUM TABLET, COATED) TABLET NAPROXEN SODIUM (NAPROXEN SODIUM, COATED TABLETS) TABLET [MARKSANS PHARMA LIMITED]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NAPROXEN SODIUM (NAPROXEN SODIUM TABLET, COATED) TABLET NAPROXEN SODIUM (NAPROXEN SODIUM, COATED TABLETS) TABLET [MARKSANS PHARMA LIMITED]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN SODIUM (NAPROXEN SODIUM TABLET, COATED) TABLET NAPROXEN SODIUM (NAPROXEN SODIUM, COATED TABLETS) TABLET [MARKSANS PHARMA LIMITED]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNAPROXEN SODIUM (NAPROXEN SODIUM TABLET, COATED) TABLET NAPROXEN SODIUM (NAPROXEN SODIUM, COATED TABLETS) TABLET [MARKSANS PHARMA LIMITED]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONAPROXEN SODIUM (NAPROXEN SODIUM TABLET, COATED) TABLET NAPROXEN SODIUM (NAPROXEN SODIUM, COATED TABLETS) TABLET [MARKSANS PHARMA LIMITED]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN SODIUM (NAPROXEN SODIUM TABLET, COATED) TABLET NAPROXEN SODIUM (NAPROXEN SODIUM, COATED TABLETS) TABLET [MARKSANS PHARMA LIMITED]3
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ANAPROXEN SODIUM (NAPROXEN SODIUM TABLET, COATED) TABLET NAPROXEN SODIUM (NAPROXEN SODIUM, COATED TABLETS) TABLET [MARKSANS PHARMA LIMITED]3
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN SODIUM (NAPROXEN SODIUM TABLET, COATED) TABLET NAPROXEN SODIUM (NAPROXEN SODIUM, COATED TABLETS) TABLET [MARKSANS PHARMA LIMITED]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAPROXEN SODIUM (NAPROXEN SODIUM TABLET, COATED) TABLET NAPROXEN SODIUM (NAPROXEN SODIUM, COATED TABLETS) TABLET [MARKSANS PHARMA LIMITED]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25000-141NAPROXEN SODIUM (NAPROXEN SODIUM TABLET, COATED) TABLET NAPROXEN SODIUM (NAPROXEN SODIUM, COATED TABLETS) TABLET [MARKSANS PHARMA LIMITED]8Current NDC, Legacy NDC, 10 package rows20230615_48cb1363-ff12-40ee-a87a-2252dfbf8ff7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN48cb1363-ff12-40ee-a87a-2252dfbf8ff78
849574naproxen sodium 220 MG Oral TabletSCD48cb1363-ff12-40ee-a87a-2252dfbf8ff78
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY48cb1363-ff12-40ee-a87a-2252dfbf8ff78

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25000-141-0225000014102160 CARTON in 1 BOX (25000-141-02) / 1 BOTTLE in 1 CARTON / 24 TABLET in 1 BOTTLE160 carton2011-05-280000-00-00NoNoCurrent
25000-141-14250000141141000 TABLET in 1 BOTTLE, PLASTIC (25000-141-14) 1000 tablet2011-05-280000-00-00NoNoCurrent
25000-141-26250000141262 BAG in 1 BOX (25000-141-26) / 1600 TABLET in 1 BAG2 bag2011-05-280000-00-00NoNoCurrent
25000-141-30250000141306 BAG in 1 BOX (25000-141-30) / 6500 TABLET in 1 BAG6 bag2011-05-280000-00-00NoNoCurrent
25000-141-432500001414310 TABLET in 1 BOTTLE (25000-141-43) 10 tablet2011-05-280000-00-00NoNoCurrent
25000-141-98250000141981 BAG in 1 BOX (25000-141-98) / 32165 TABLET in 1 BAG1 bag2011-05-280000-00-00NoNoCurrent