FDA.reportPublic FDA data

Naproxen

Product NDC
65162-190
11-digit product format
651620190
Labeler code
65162
Product ID
65162-190_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
500 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
NAPROXEN500 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
65162-190-10Naproxen100 in 1 BOTTLETABLET10030
65162-190-11Naproxen1000 in 1 BOTTLETABLET100030
65162-190-50Naproxen500 in 1 BOTTLETABLET50030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-190-10EA - Each65162-1905d202877-344a-41d3-9052-0b544e3cf3dd12014-12-01
65162-190-11EA - Each65162-1900cda3a04-6fba-4867-b897-9057702c9e0312014-12-01
65162-190-50EA - Each65162-19095ffe6ca-3d68-4ba7-b0c3-995047c64ec812014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
65162-190NAPROXEN 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
198014naproxen 500 MG Oral TabletPSNa4f31070-4ee1-4d64-8b1d-40b9011e124b15
198014naproxen 500 MG Oral TabletSCDa4f31070-4ee1-4d64-8b1d-40b9011e124b15
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
198014naproxen 500 MG Oral TabletPSNc5e52ddd-a909-487a-bb46-01ad356906658
198014naproxen 500 MG Oral TabletPSNaf9a94a8-3825-eabd-e053-2a95a90acd588
198014naproxen 500 MG Oral TabletPSN307aa67f-53b9-4c60-a328-091bbf6338d48
198014naproxen 500 MG Oral TabletSCDc5e52ddd-a909-487a-bb46-01ad356906658
198014naproxen 500 MG Oral TabletSCDaf9a94a8-3825-eabd-e053-2a95a90acd588
198014naproxen 500 MG Oral TabletSCD307aa67f-53b9-4c60-a328-091bbf6338d48
198014naproxen 500 MG Oral TabletPSN73a0bc52-14c7-4b33-bfe3-bd44f79b5bd57
198014naproxen 500 MG Oral TabletPSN51f1a9ee-a925-3bde-e054-00144ff88e887
198014naproxen 500 MG Oral TabletPSN50217b0f-a696-6c82-e054-00144ff88e887
198014naproxen 500 MG Oral TabletSCD73a0bc52-14c7-4b33-bfe3-bd44f79b5bd57
198014naproxen 500 MG Oral TabletSCD51f1a9ee-a925-3bde-e054-00144ff88e887
198014naproxen 500 MG Oral TabletSCD50217b0f-a696-6c82-e054-00144ff88e887
198014naproxen 500 MG Oral TabletPSNab6ec2c9-5df9-346c-e053-2a95a90ac81d6
198014naproxen 500 MG Oral TabletSCDab6ec2c9-5df9-346c-e053-2a95a90ac81d6
198014naproxen 500 MG Oral TabletPSN386c4da7-0b0c-458e-95c0-bf224029bf963
198014naproxen 500 MG Oral TabletSCD386c4da7-0b0c-458e-95c0-bf224029bf963
198014naproxen 500 MG Oral TabletPSNbcf577bc-ab10-5c15-e053-2995a90a9c581
198014naproxen 500 MG Oral TabletPSN9d7bc470-fbba-40a6-a56c-f681a3cee9cf1
198014naproxen 500 MG Oral TabletPSN62a12771-bde9-4bc3-9ce9-672c8e31f0201
198014naproxen 500 MG Oral TabletSCD62a12771-bde9-4bc3-9ce9-672c8e31f0201
198014naproxen 500 MG Oral TabletSCD9d7bc470-fbba-40a6-a56c-f681a3cee9cf1
198014naproxen 500 MG Oral TabletSCDbcf577bc-ab10-5c15-e053-2995a90a9c581

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-190-1065162019010100 TABLET in 1 BOTTLE (65162-190-10) 100 tablet2010-02-180000-00-00NoNoCurrent
65162-190-11651620190111000 TABLET in 1 BOTTLE (65162-190-11) 1000 tablet2010-02-180000-00-00NoNoCurrent
65162-190-5065162019050500 TABLET in 1 BOTTLE (65162-190-50) 500 tablet2010-02-180000-00-00NoNoCurrent