FDA.reportPublic FDA data

Naproxen

Product NDC
65162-188
11-digit product format
651620188
Labeler code
65162
Product ID
65162-188_691465d4-c26e-4118-9578-bec8d788f33b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA075927
Marketing category
ANDA
Marketing start
2010-02-18
Substance
NAPROXEN
Active strength
250 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
NAPROXEN250 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-188-10Naproxen100 in 1 BOTTLETABLET10030
65162-188-11Naproxen1000 in 1 BOTTLETABLET100030
65162-188-50Naproxen500 in 1 BOTTLETABLET50030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-188-10EA - Each65162-1885e8449be-9470-418d-9f29-bc2dc638ccdb12014-12-01
65162-188-11EA - Each65162-188d3847908-5b0c-483b-8dff-9e9adc4e8c1612014-12-01
65162-188-50EA - Each65162-18877be147e-0e2a-43f7-91ef-edabf360cfc712014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [PD-RX PHARMACEUTICALS, INC.]10
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [PD-RX PHARMACEUTICALS, INC.]10
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [PD-RX PHARMACEUTICALS, INC.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [PD-RX PHARMACEUTICALS, INC.]10
POVIDONESINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [PD-RX PHARMACEUTICALS, INC.]10
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
POVIDONESINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [AVPAK]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [AVPAK]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [AVPAK]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [AVPAK]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [AVPAK]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-188NAPROXEN TABLET [AMNEAL PHARMACEUTICALS LLC]29Current NDC, Legacy NDC, 3 package rows20241031_c43a43e2-e867-448d-8f59-3efc7c077cbc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198013naproxen 250 MG Oral TabletPSNc43a43e2-e867-448d-8f59-3efc7c077cbc30
198012naproxen 375 MG Oral TabletPSNc43a43e2-e867-448d-8f59-3efc7c077cbc30
198014naproxen 500 MG Oral TabletPSNc43a43e2-e867-448d-8f59-3efc7c077cbc30
198013naproxen 250 MG Oral TabletSCDc43a43e2-e867-448d-8f59-3efc7c077cbc30
198012naproxen 375 MG Oral TabletSCDc43a43e2-e867-448d-8f59-3efc7c077cbc30
198014naproxen 500 MG Oral TabletSCDc43a43e2-e867-448d-8f59-3efc7c077cbc30
198013naproxen 250 MG Oral TabletPSN6573681e-e9be-440f-a818-a533b744648e25
198013naproxen 250 MG Oral TabletSCD6573681e-e9be-440f-a818-a533b744648e25
198013naproxen 250 MG Oral TabletPSNe6fbf8f1-b064-658d-17bb-e7d6320aa45f10
198012naproxen 375 MG Oral TabletPSNe6fbf8f1-b064-658d-17bb-e7d6320aa45f10
198014naproxen 500 MG Oral TabletPSNe6fbf8f1-b064-658d-17bb-e7d6320aa45f10
198013naproxen 250 MG Oral TabletSCDe6fbf8f1-b064-658d-17bb-e7d6320aa45f10
198012naproxen 375 MG Oral TabletSCDe6fbf8f1-b064-658d-17bb-e7d6320aa45f10
198014naproxen 500 MG Oral TabletSCDe6fbf8f1-b064-658d-17bb-e7d6320aa45f10
198013naproxen 250 MG Oral TabletPSN21930f73-d3c2-4462-a487-74ed871b74b28
198013naproxen 250 MG Oral TabletSCD21930f73-d3c2-4462-a487-74ed871b74b28
198013naproxen 250 MG Oral TabletPSN35b8ec82-725f-5925-e054-00144ff8d46c2
198013naproxen 250 MG Oral TabletSCD35b8ec82-725f-5925-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-188-1065162018810100 TABLET in 1 BOTTLE (65162-188-10) 100 tablet2010-02-180000-00-00NoNoCurrent
65162-188-11651620188111000 TABLET in 1 BOTTLE (65162-188-11) 1000 tablet2010-02-180000-00-00NoNoCurrent
65162-188-5065162018850500 TABLET in 1 BOTTLE (65162-188-50) 500 tablet2010-02-180000-00-00NoNoCurrent