Naproxen Sodium

Product NDC
45865-519
11-digit product format
458650519
Labeler code
45865
Product ID
45865-519_9ab2e268-cd9d-8932-e053-2a95a90ad7a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA078314
Marketing category
ANDA
Marketing start
2007-08-01
Marketing end
0000-00-00
Substance
NAPROXEN SODIUM
Active strength
275 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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
45865-519-302025-01-30C16284748780-12cef2736-7d95-d83d-e063-dadaa90ab31fNAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-519-30Naproxen Sodium30 in 1 BOTTLETABLET303

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN SODIUM TABLET [MEDSOURCE PHARMACEUTICALS]2
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN SODIUM TABLET [MEDSOURCE PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNAPROXEN SODIUM TABLET [MEDSOURCE PHARMACEUTICALS]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN SODIUM TABLET [MEDSOURCE PHARMACEUTICALS]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNAPROXEN SODIUM TABLET [MEDSOURCE PHARMACEUTICALS]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NAPROXEN SODIUM TABLET [MEDSOURCE PHARMACEUTICALS]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONAPROXEN SODIUM TABLET [MEDSOURCE PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN SODIUM TABLET [MEDSOURCE PHARMACEUTICALS]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQNAPROXEN SODIUM TABLET [MEDSOURCE PHARMACEUTICALS]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ENAPROXEN SODIUM TABLET [MEDSOURCE PHARMACEUTICALS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NAPROXEN SODIUM TABLET [MEDSOURCE PHARMACEUTICALS]2
TALCINACTIVE INGREDIENT7SEV7J4R1UNAPROXEN SODIUM TABLET [MEDSOURCE PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAPROXEN SODIUM TABLET [MEDSOURCE PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-519NAPROXEN SODIUM TABLET [MEDSOURCE PHARMACEUTICALS]3Legacy NDC, 1 package rows20191228_1ea7e83b-e28b-17f7-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849398naproxen sodium 275 MG Oral TabletPSN1ea7e83b-e28b-17f7-e054-00144ff8d46c3
849398naproxen sodium 275 MG Oral TabletSCD1ea7e83b-e28b-17f7-e054-00144ff8d46c3
849398naproxen sodium 275 MG (as naproxen 250 MG) Oral TabletSY1ea7e83b-e28b-17f7-e054-00144ff8d46c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-519-304586505193030 TABLET in 1 BOTTLE (45865-519-30) 30 tablet2015-09-010000-00-00NoNoCurrent