FDA.reportPublic FDA data

Naproxen

Product NDC
65862-520
11-digit product format
658620520
Labeler code
65862
Product ID
65862-520_51d52d13-f5c1-4e80-8cb9-4aa72ad94103
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA200429
Marketing category
ANDA
Marketing start
2011-11-08
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
65862-520-01Naproxen100 in 1 BOTTLETABLET10016
65862-520-05Naproxen500 in 1 BOTTLETABLET50016
65862-520-10Naproxen10 in 1 BLISTER PACKTABLET1016
65862-520-10Naproxen10 in 1 CARTONTABLET1016
65862-520-99Naproxen1000 in 1 BOTTLETABLET100016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-520-01EA - Each65862-5205b042ee6-4dbb-4f09-a4c2-f9a11356dbf012012-07-24
65862-520-05EA - Each65862-520fe2a03a6-3615-46f3-9403-66c6813d73f012012-07-24
65862-520-99EA - Each65862-5201ae4a124-63cb-4465-90dd-018b702c03b312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [AUROBINDO PHARMA LIMITED]3
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [AUROBINDO PHARMA LIMITED]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNAPROXEN TABLET [AUROBINDO PHARMA LIMITED]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNAPROXEN TABLET [AUROBINDO PHARMA LIMITED]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [AUROBINDO PHARMA LIMITED]3
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQNAPROXEN TABLET [AUROBINDO PHARMA LIMITED]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2NAPROXEN TABLET [AUROBINDO PHARMA LIMITED]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNAPROXEN TABLET [AUROBINDO PHARMA LIMITED]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-520NAPROXEN TABLET [AUROBINDO PHARMA LIMITED]15Current NDC, Legacy NDC, 5 package rows20241213_0e5315bc-c02f-4749-be69-b5b528327d58.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198013naproxen 250 MG Oral TabletPSN0e5315bc-c02f-4749-be69-b5b528327d5816
198012naproxen 375 MG Oral TabletPSN0e5315bc-c02f-4749-be69-b5b528327d5816
198014naproxen 500 MG Oral TabletPSN0e5315bc-c02f-4749-be69-b5b528327d5816
198013naproxen 250 MG Oral TabletSCD0e5315bc-c02f-4749-be69-b5b528327d5816
198012naproxen 375 MG Oral TabletSCD0e5315bc-c02f-4749-be69-b5b528327d5816
198014naproxen 500 MG Oral TabletSCD0e5315bc-c02f-4749-be69-b5b528327d5816

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-520-0165862052001100 TABLET in 1 BOTTLE (65862-520-01) 100 tablet2011-11-080000-00-00NoNoCurrent
65862-520-0565862052005500 TABLET in 1 BOTTLE (65862-520-05) 500 tablet2011-11-080000-00-00NoNoCurrent
65862-520-106586205201010 BLISTER PACK in 1 CARTON (65862-520-10) / 10 TABLET in 1 BLISTER PACK10 blister pack2011-11-080000-00-00NoNoCurrent
65862-520-35658620520353500 TABLET in 1 BAG (65862-520-35)3500 tablet08-NOV-11Current
65862-520-99658620520991000 TABLET in 1 BOTTLE (65862-520-99) 1000 tablet2011-11-080000-00-00NoNoCurrent