NAPROXEN

Product NDC
61919-586
11-digit product format
619190586
Labeler code
61919
Product ID
61919-586_9ca985c6-503e-0558-e053-2995a90a8202
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NAPROXEN
Dosage form
TABLET
Route
ORAL
Labeler
DirectRX
Application
ANDA091305
Marketing category
ANDA
Marketing start
2015-01-01
Marketing end
0000-00-00
Substance
NAPROXEN
Active strength
500 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
2021-12-31
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
61919-586-142023-01-30C16284748780-1f386c64a-4659-0266-e053-dadaa90a7c1aNAPROXEN
61919-586-202023-01-30C16284748780-1f386c64a-4659-0266-e053-dadaa90a7c1aNAPROXEN
61919-586-602023-01-30C16284748780-1f386c64a-4659-0266-e053-dadaa90a7c1aNAPROXEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-586-14NAPROXEN14 in 1 BOTTLETABLET144
61919-586-20NAPROXEN20 in 1 BOTTLETABLET204
61919-586-60NAPROXEN60 in 1 BOTTLETABLET604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-586-14EA - Each61919-586746dc2b6-2b20-4075-9daf-db037797186e12016-09-02
61919-586-20EA - Each61919-586845f3df9-d837-4bd7-a578-9d3b5dac3d5612016-09-02
61919-586-60EA - Each61919-5862e23789a-8313-400c-bb94-a17ea4223d9d12016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [DIRECTRX]2
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [DIRECTRX]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [DIRECTRX]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNAPROXEN TABLET [DIRECTRX]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [DIRECTRX]2
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [DIRECTRX]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NAPROXEN TABLET [DIRECTRX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-586NAPROXEN TABLET [DIRECTRX]4Legacy NDC, 3 package rows20200130_50c696da-0ea6-4d76-b50e-fb0b55ff77ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSN50c696da-0ea6-4d76-b50e-fb0b55ff77ae4
198014naproxen 500 MG Oral TabletSCD50c696da-0ea6-4d76-b50e-fb0b55ff77ae4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-586-146191905861414 TABLET in 1 BOTTLE (61919-586-14) 14 tablet2015-01-010000-00-00NoNoCurrent
61919-586-206191905862020 TABLET in 1 BOTTLE (61919-586-20) 20 tablet2015-01-010000-00-00NoNoCurrent
61919-586-606191905866060 TABLET in 1 BOTTLE (61919-586-60) 60 tablet2015-01-010000-00-00NoNoCurrent