FDA.reportPublic FDA data

Naproxen sodium

Product NDC
71335-1650
11-digit product format
713351650
Labeler code
71335
Product ID
71335-1650_2bd1f190-c76c-4003-9ab9-1c6c27dde97a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078486
Marketing category
ANDA
Marketing start
2016-04-26
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
Rxcui849431

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1650-02024-08-21C16284748780-11030e365-359e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976
71335-1650-12024-08-21C16284748780-11030e365-359e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976
71335-1650-22024-08-21C16284748780-11030e365-359e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976
71335-1650-32024-08-21C16284748780-11030e365-359e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976
71335-1650-42024-08-21C16284748780-11030e365-359e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976
71335-1650-52024-08-21C16284748780-11030e365-359e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976
71335-1650-62024-08-21C16284748780-11030e365-359e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976
71335-1650-72024-08-21C16284748780-11030e365-359e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976
71335-1650-82024-08-21C16284748780-11030e365-359e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976
71335-1650-92024-08-21C16284748780-11030e365-359e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976
71335-1650-02024-01-30C16284748780-11030e365-359e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976
71335-1650-12024-01-30C16284748780-11030e365-359e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976
71335-1650-22024-01-30C16284748780-11030e365-359e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976
71335-1650-32024-01-30C16284748780-11030e365-359e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976
71335-1650-42024-01-30C16284748780-11030e365-359e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976
71335-1650-52024-01-30C16284748780-11030e365-359e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976
71335-1650-62024-01-30C16284748780-11030e365-359e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976
71335-1650-72024-01-30C16284748780-11030e365-359e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976
71335-1650-82024-01-30C16284748780-11030e365-359e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976
71335-1650-92024-01-30C16284748780-11030e365-359e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1650-0Naproxen sodium6 in 1 BOTTLETABLET, FILM COATED63
71335-1650-1Naproxen sodium20 in 1 BOTTLETABLET, FILM COATED203
71335-1650-2Naproxen sodium100 in 1 BOTTLETABLET, FILM COATED1003
71335-1650-3Naproxen sodium30 in 1 BOTTLETABLET, FILM COATED303
71335-1650-4Naproxen sodium120 in 1 BOTTLETABLET, FILM COATED1203
71335-1650-5Naproxen sodium60 in 1 BOTTLETABLET, FILM COATED603
71335-1650-6Naproxen sodium90 in 1 BOTTLETABLET, FILM COATED903
71335-1650-7Naproxen sodium42 in 1 BOTTLETABLET, FILM COATED423
71335-1650-8Naproxen sodium14 in 1 BOTTLETABLET, FILM COATED143
71335-1650-9Naproxen sodium56 in 1 BOTTLETABLET, FILM COATED563

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1650NAPROXEN SODIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]3Current NDC, Legacy NDC, 10 package rows20240823_42f6a3a0-5a1e-40ca-8949-b8870dd95d2e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849431naproxen sodium 550 MG Oral TabletPSN42f6a3a0-5a1e-40ca-8949-b8870dd95d2e3
849431naproxen sodium 550 MG Oral TabletSCD42f6a3a0-5a1e-40ca-8949-b8870dd95d2e3
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY42f6a3a0-5a1e-40ca-8949-b8870dd95d2e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1650-0713351650006 TABLET, FILM COATED in 1 BOTTLE (71335-1650-0) 2024-08-120000-00-00NoNoCurrent
71335-1650-17133516500120 TABLET, FILM COATED in 1 BOTTLE (71335-1650-1) 2024-08-120000-00-00NoNoCurrent
71335-1650-271335165002100 TABLET, FILM COATED in 1 BOTTLE (71335-1650-2) 2024-08-120000-00-00NoNoCurrent
71335-1650-37133516500330 TABLET, FILM COATED in 1 BOTTLE (71335-1650-3) 2020-06-230000-00-00NoNoCurrent
71335-1650-471335165004120 TABLET, FILM COATED in 1 BOTTLE (71335-1650-4) 2024-08-120000-00-00NoNoCurrent
71335-1650-57133516500560 TABLET, FILM COATED in 1 BOTTLE (71335-1650-5) 2024-08-120000-00-00NoNoCurrent
71335-1650-67133516500690 TABLET, FILM COATED in 1 BOTTLE (71335-1650-6) 2024-08-120000-00-00NoNoCurrent
71335-1650-77133516500742 TABLET, FILM COATED in 1 BOTTLE (71335-1650-7) 2024-08-120000-00-00NoNoCurrent
71335-1650-87133516500814 TABLET, FILM COATED in 1 BOTTLE (71335-1650-8) 2024-08-120000-00-00NoNoCurrent
71335-1650-97133516500956 TABLET, FILM COATED in 1 BOTTLE (71335-1650-9) 2024-08-120000-00-00NoNoCurrent