FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
65862-516
11-digit product format
658620516
Labeler code
65862
Product ID
65862-516_a4659cf5-a74b-42b3-968b-a8e4f14f94aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA200629
Marketing category
ANDA
Marketing start
2011-10-31
Substance
NAPROXEN SODIUM
Active strength
550 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 Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN SODIUM550 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9TN87S3A3C
Rxcui849398, 849431

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
65862-516-01Naproxen Sodium100 in 1 BOTTLETABLET, FILM COATED10012
65862-516-05Naproxen Sodium500 in 1 BOTTLETABLET, FILM COATED50012
65862-516-26Naproxen Sodium2500 in 1 BOTTLETABLET, FILM COATED250012
65862-516-30Naproxen Sodium30 in 1 BOTTLETABLET, FILM COATED3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-516-01EA - Each65862-516a611a48c-36ba-4bc1-9f50-f61c79b7820112016-12-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]2
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNAPROXEN SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNAPROXEN SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]2
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4NAPROXEN SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6NAPROXEN SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]2
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BNAPROXEN SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XNAPROXEN SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NAPROXEN SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]2
TALCINACTIVE INGREDIENT7SEV7J4R1UNAPROXEN SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAPROXEN SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-516NAPROXEN SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]11Current NDC, Legacy NDC, 4 package rows20241225_37b264f9-b46d-4635-8fab-246b1e08b653.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849398naproxen sodium 275 MG Oral TabletPSN37b264f9-b46d-4635-8fab-246b1e08b65312
849431naproxen sodium 550 MG Oral TabletPSN37b264f9-b46d-4635-8fab-246b1e08b65312
849398naproxen sodium 275 MG Oral TabletSCD37b264f9-b46d-4635-8fab-246b1e08b65312
849431naproxen sodium 550 MG Oral TabletSCD37b264f9-b46d-4635-8fab-246b1e08b65312
849398naproxen sodium 275 MG (as naproxen 250 MG) Oral TabletSY37b264f9-b46d-4635-8fab-246b1e08b65312
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY37b264f9-b46d-4635-8fab-246b1e08b65312
849431naproxen sodium 550 MG Oral TabletPSN0e7697ad-25c6-4405-9f9b-791633cb1ef78
849431naproxen sodium 550 MG Oral TabletSCD0e7697ad-25c6-4405-9f9b-791633cb1ef78
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY0e7697ad-25c6-4405-9f9b-791633cb1ef78
849431naproxen sodium 550 MG Oral TabletPSN397db794-027c-4a89-993e-07c208b457a31
849431naproxen sodium 550 MG Oral TabletPSN63478341-bcf8-43ea-803f-6d5d10875cfe1
849431naproxen sodium 550 MG Oral TabletSCD397db794-027c-4a89-993e-07c208b457a31
849431naproxen sodium 550 MG Oral TabletSCD63478341-bcf8-43ea-803f-6d5d10875cfe1
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY397db794-027c-4a89-993e-07c208b457a31
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY63478341-bcf8-43ea-803f-6d5d10875cfe1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-516-0165862051601100 TABLET, FILM COATED in 1 BOTTLE (65862-516-01) 2011-10-310000-00-00NoNoCurrent
65862-516-0565862051605500 TABLET, FILM COATED in 1 BOTTLE (65862-516-05) 2011-10-310000-00-00NoNoCurrent
65862-516-26658620516262500 TABLET, FILM COATED in 1 BOTTLE (65862-516-26) 2011-10-310000-00-00NoNoCurrent
65862-516-306586205163030 TABLET, FILM COATED in 1 BOTTLE (65862-516-30) 2011-10-310000-00-00NoNoCurrent