FDA.reportPublic FDA data

Naproxen Sodium (NSAID)

Product NDC
53746-192
11-digit product format
537460192
Labeler code
53746
Product ID
53746-192_9cc39ab5-450a-4e0b-948d-fdebd66c0f6f
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA079096
Marketing category
ANDA
Marketing start
2009-11-25
Substance
NAPROXEN SODIUM
Active strength
220 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 (NSAID)
Brand name suffix
Fever Reducer/ Pain Reliever
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN SODIUM220 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9TN87S3A3C
Rxcui849574

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
53746-192-05Naproxen Sodium (NSAID)Fever Reducer/ Pain Reliever500 in 1 BOTTLETABLET50013
53746-192-08Naproxen Sodium (NSAID)Fever Reducer/ Pain Reliever8 in 1 VIALTABLET813
53746-192-24Naproxen Sodium (NSAID)Fever Reducer/ Pain Reliever24 in 1 BOTTLETABLET2413

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN SODIUM (NSAID) FEVER REDUCER/ PAIN RELIEVER (NAPROXEN SODIUM) TABLET [AMNEAL PHARMACEUTICALS]4
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN SODIUM (NSAID) FEVER REDUCER/ PAIN RELIEVER (NAPROXEN SODIUM) TABLET [AMNEAL PHARMACEUTICALS]4
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]2
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53746-192NAPROXEN SODIUM (NSAID) FEVER REDUCER/ PAIN RELIEVER (NAPROXEN SODIUM) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]13Current NDC, Legacy NDC, 3 package rows20240101_0bb41b8c-6031-4e96-95e1-31adab811837.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN0bb41b8c-6031-4e96-95e1-31adab81183713
849574naproxen sodium 220 MG Oral TabletSCD0bb41b8c-6031-4e96-95e1-31adab81183713
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY0bb41b8c-6031-4e96-95e1-31adab81183713
849574naproxen sodium 220 MG Oral TabletPSNce6e9b4b-281c-4336-a878-bb35b3b301df2
849574naproxen sodium 220 MG Oral TabletSCDce6e9b4b-281c-4336-a878-bb35b3b301df2
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSYce6e9b4b-281c-4336-a878-bb35b3b301df2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53746-192-0553746019205500 TABLET in 1 BOTTLE (53746-192-05) 500 tablet2009-11-250000-00-00NoNoCurrent
53746-192-08537460192088 TABLET in 1 VIAL (53746-192-08) 8 tablet2009-11-250000-00-00NoNoCurrent
53746-192-245374601922424 TABLET in 1 BOTTLE (53746-192-24) 24 tablet2009-11-250000-00-00NoNoCurrent