FDA.reportPublic FDA data

Naproxen

Product NDC
53746-189
11-digit product format
537460189
Labeler code
53746
Product ID
53746-189_e54d008a-9b47-42fa-a8c1-23dc72527132
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA075927
Marketing category
ANDA
Marketing start
2010-02-18
Substance
NAPROXEN
Active strength
375 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN375 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57Y76R9ATQ
Rxcui198012, 198013, 198014

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53746-189-012021-02-17C16284748780-1ba0f9c33-3d41-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
53746-189-052021-02-17C16284748780-1ba0f9c33-3d41-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
53746-189-102021-02-17C16284748780-1ba0f9c33-3d41-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
53746-189-012021-01-29C16284748780-1ba0f9c33-3d41-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
53746-189-052021-01-29C16284748780-1ba0f9c33-3d41-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
53746-189-102021-01-29C16284748780-1ba0f9c33-3d41-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53746-189-01Naproxen100 in 1 BOTTLETABLET10027
53746-189-05Naproxen500 in 1 BOTTLETABLET50027
53746-189-10Naproxen1000 in 1 BOTTLETABLET100027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53746-189-01EA - Each53746-189ef22edfa-8bba-4253-85c1-44af3e726c1212012-07-24
53746-189-05EA - Each53746-1894251cc0e-1e39-4572-9506-9d1023c6cb1812012-07-24
53746-189-10EA - Each53746-1899e2d2eb0-06bb-4773-a95c-5b5d1613bcd912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
POVIDONESINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [DISPENSING SOLUTIONS, INC.]5
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [DISPENSING SOLUTIONS, INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [DISPENSING SOLUTIONS, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [DISPENSING SOLUTIONS, INC.]5
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [DISPENSING SOLUTIONS, INC.]5
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [REBEL DISTRIBUTORS CORP.]3
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [REBEL DISTRIBUTORS CORP.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [REBEL DISTRIBUTORS CORP.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [REBEL DISTRIBUTORS CORP.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [REBEL DISTRIBUTORS CORP.]3
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [PREFERRED PHARMACEUTICALS, INC.]2
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [KELTMAN PHARMACEUTICALS INC.]2
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [KELTMAN PHARMACEUTICALS INC.]2
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [PREFERRED PHARMACEUTICALS, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [PREFERRED PHARMACEUTICALS, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [KELTMAN PHARMACEUTICALS INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [PREFERRED PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [KELTMAN PHARMACEUTICALS INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [KELTMAN PHARMACEUTICALS INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [PREFERRED PHARMACEUTICALS, INC.]2
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [STAT RX USA LLC]1
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [BLENHEIM PHARMACAL, INC.]1
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [AIDAREX PHARMACEUTICALS LLC]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [STAT RX USA LLC]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [BLENHEIM PHARMACAL, INC.]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [AIDAREX PHARMACEUTICALS LLC]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [AIDAREX PHARMACEUTICALS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [BLENHEIM PHARMACAL, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [STAT RX USA LLC]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [BLENHEIM PHARMACAL, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [STAT RX USA LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53746-189NAPROXEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]27Current NDC, Legacy NDC, 3 package rows20250316_2718e0b7-1ce6-457e-bee9-11b634dfd353.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198013naproxen 250 MG Oral TabletPSN53865075-2d8d-4390-b392-5645cfd90e7b34
198012naproxen 375 MG Oral TabletPSN53865075-2d8d-4390-b392-5645cfd90e7b34
198014naproxen 500 MG Oral TabletPSN53865075-2d8d-4390-b392-5645cfd90e7b34
198013naproxen 250 MG Oral TabletSCD53865075-2d8d-4390-b392-5645cfd90e7b34
198012naproxen 375 MG Oral TabletSCD53865075-2d8d-4390-b392-5645cfd90e7b34
198014naproxen 500 MG Oral TabletSCD53865075-2d8d-4390-b392-5645cfd90e7b34
198013naproxen 250 MG Oral TabletPSN2718e0b7-1ce6-457e-bee9-11b634dfd35327
198012naproxen 375 MG Oral TabletPSN2718e0b7-1ce6-457e-bee9-11b634dfd35327
198014naproxen 500 MG Oral TabletPSN2718e0b7-1ce6-457e-bee9-11b634dfd35327
198013naproxen 250 MG Oral TabletSCD2718e0b7-1ce6-457e-bee9-11b634dfd35327
198012naproxen 375 MG Oral TabletSCD2718e0b7-1ce6-457e-bee9-11b634dfd35327
198014naproxen 500 MG Oral TabletSCD2718e0b7-1ce6-457e-bee9-11b634dfd35327
198012naproxen 375 MG Oral TabletPSN413a5d58-f37c-4e50-bfc4-fe2000df25ac5
198012naproxen 375 MG Oral TabletSCD413a5d58-f37c-4e50-bfc4-fe2000df25ac5
198013naproxen 250 MG Oral TabletPSN8c7b265e-7500-464a-854e-9c4a22c8d2113
198013naproxen 250 MG Oral TabletPSN92c48cd9-e645-4871-a0ad-9ea56623edb63
198012naproxen 375 MG Oral TabletPSN8c7b265e-7500-464a-854e-9c4a22c8d2113
198012naproxen 375 MG Oral TabletPSN92c48cd9-e645-4871-a0ad-9ea56623edb63
198012naproxen 375 MG Oral TabletPSN6d757241-53f8-4498-999a-87dfe3cb4d173
198014naproxen 500 MG Oral TabletPSN6d757241-53f8-4498-999a-87dfe3cb4d173
198014naproxen 500 MG Oral TabletPSN8c7b265e-7500-464a-854e-9c4a22c8d2113
198014naproxen 500 MG Oral TabletPSN92c48cd9-e645-4871-a0ad-9ea56623edb63
198013naproxen 250 MG Oral TabletSCD8c7b265e-7500-464a-854e-9c4a22c8d2113
198013naproxen 250 MG Oral TabletSCD92c48cd9-e645-4871-a0ad-9ea56623edb63
198012naproxen 375 MG Oral TabletSCD8c7b265e-7500-464a-854e-9c4a22c8d2113
198012naproxen 375 MG Oral TabletSCD92c48cd9-e645-4871-a0ad-9ea56623edb63
198012naproxen 375 MG Oral TabletSCD6d757241-53f8-4498-999a-87dfe3cb4d173
198014naproxen 500 MG Oral TabletSCD8c7b265e-7500-464a-854e-9c4a22c8d2113
198014naproxen 500 MG Oral TabletSCD92c48cd9-e645-4871-a0ad-9ea56623edb63
198014naproxen 500 MG Oral TabletSCD6d757241-53f8-4498-999a-87dfe3cb4d173
198013naproxen 250 MG Oral TabletPSN1a10952e-0662-4f2c-bd02-28dd4eee138f2
198012naproxen 375 MG Oral TabletPSN1a10952e-0662-4f2c-bd02-28dd4eee138f2
198014naproxen 500 MG Oral TabletPSN1a10952e-0662-4f2c-bd02-28dd4eee138f2
198013naproxen 250 MG Oral TabletSCD1a10952e-0662-4f2c-bd02-28dd4eee138f2
198012naproxen 375 MG Oral TabletSCD1a10952e-0662-4f2c-bd02-28dd4eee138f2
198014naproxen 500 MG Oral TabletSCD1a10952e-0662-4f2c-bd02-28dd4eee138f2
198013naproxen 250 MG Oral TabletPSN6b10c3ff-7cd9-4a59-9436-d2c6a64e4a691
198012naproxen 375 MG Oral TabletPSN97b051b0-65e1-4797-b72d-96f7ac623d1d1
198012naproxen 375 MG Oral TabletPSNf14e79d3-a8e9-46fd-9959-639343c1c6421
198012naproxen 375 MG Oral TabletPSN6b10c3ff-7cd9-4a59-9436-d2c6a64e4a691
198012naproxen 375 MG Oral TabletPSN2a6133ff-285d-4026-bbd6-e99f84b638201
198013naproxen 250 MG Oral TabletSCD6b10c3ff-7cd9-4a59-9436-d2c6a64e4a691
198012naproxen 375 MG Oral TabletSCD6b10c3ff-7cd9-4a59-9436-d2c6a64e4a691
198012naproxen 375 MG Oral TabletSCD97b051b0-65e1-4797-b72d-96f7ac623d1d1
198012naproxen 375 MG Oral TabletSCDf14e79d3-a8e9-46fd-9959-639343c1c6421
198012naproxen 375 MG Oral TabletSCD2a6133ff-285d-4026-bbd6-e99f84b638201

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53746-189-0153746018901100 TABLET in 1 BOTTLE (53746-189-01) 100 tablet2010-02-180000-00-00NoNoCurrent
53746-189-0553746018905500 TABLET in 1 BOTTLE (53746-189-05) 500 tablet2010-02-180000-00-00NoNoCurrent
53746-189-10537460189101000 TABLET in 1 BOTTLE (53746-189-10) 1000 tablet2010-02-180000-00-00NoNoCurrent