Naproxen

Product NDC
65862-522
11-digit product format
658620522
Labeler code
65862
Product ID
65862-522_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
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
65862-522-01Naproxen100 in 1 BOTTLETABLET10016
65862-522-05Naproxen500 in 1 BOTTLETABLET50016
65862-522-26Naproxen2500 in 1 BOTTLETABLET250016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-522-01EA - Each65862-5224c3ffeea-fc54-426f-a607-c04e5a189ab112012-07-24
65862-522-05EA - Each65862-5227c521228-590f-4966-b245-77abeaddaea412012-07-24

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
65862-522NAPROXEN TABLET [AUROBINDO PHARMA LIMITED]15Current NDC, Legacy NDC, 3 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
198014naproxen 500 MG Oral TabletPSNaf9ac948-4405-5abf-e053-2995a90af2b56
198014naproxen 500 MG Oral TabletSCDaf9ac948-4405-5abf-e053-2995a90af2b56
198014naproxen 500 MG Oral TabletPSN0b25daa0-a8d6-d7f7-e063-6394a90a2cb03
198014naproxen 500 MG Oral TabletSCD0b25daa0-a8d6-d7f7-e063-6394a90a2cb03
198014naproxen 500 MG Oral TabletPSNe0f430fd-4511-41c8-b5e9-894abe4f3c371
198014naproxen 500 MG Oral TabletPSNd801ba16-e2ec-4bb2-8cff-32388634b35a1
198014naproxen 500 MG Oral TabletPSNa8b54258-84e7-41e8-9e51-137a3f442e6b1
198014naproxen 500 MG Oral TabletPSNf91c1a6b-b256-42e1-9da0-5f1975dec6ce1
198014naproxen 500 MG Oral TabletPSN50c52976-9e04-4a5e-9f21-aca3ea5c29241
198014naproxen 500 MG Oral TabletPSN3375e139-d9de-8c2d-e063-6394a90a653d1
198014naproxen 500 MG Oral TabletSCDe0f430fd-4511-41c8-b5e9-894abe4f3c371
198014naproxen 500 MG Oral TabletSCDf91c1a6b-b256-42e1-9da0-5f1975dec6ce1
198014naproxen 500 MG Oral TabletSCDd801ba16-e2ec-4bb2-8cff-32388634b35a1
198014naproxen 500 MG Oral TabletSCDa8b54258-84e7-41e8-9e51-137a3f442e6b1
198014naproxen 500 MG Oral TabletSCD50c52976-9e04-4a5e-9f21-aca3ea5c29241
198014naproxen 500 MG Oral TabletSCD3375e139-d9de-8c2d-e063-6394a90a653d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-522-0165862052201100 TABLET in 1 BOTTLE (65862-522-01) 100 tablet2011-11-080000-00-00NoNoCurrent
65862-522-0565862052205500 TABLET in 1 BOTTLE (65862-522-05) 500 tablet2011-11-080000-00-00NoNoCurrent
65862-522-22658620522222000 TABLET in 1 BAG (65862-522-22)2000 tablet08-NOV-11Current
65862-522-26658620522262500 TABLET in 1 BOTTLE (65862-522-26) 2500 tablet2011-11-080000-00-00NoNoCurrent