FDA.reportPublic FDA data

Naproxen

Product NDC
63187-455
11-digit product format
631870455
Labeler code
63187
Product ID
63187-455_bb54c7fc-15f8-4e1c-8095-aacab4b8f68d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA075927
Marketing category
ANDA
Marketing start
2010-02-18
Substance
NAPROXEN
Active strength
500 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57Y76R9ATQ
Rxcui198014

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-455-20Naproxen20 in 1 BOTTLETABLET205
63187-455-30Naproxen30 in 1 BOTTLETABLET305
63187-455-60Naproxen60 in 1 BOTTLETABLET605
63187-455-90Naproxen90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-455-20EA - Each63187-4555d73a381-ce39-4570-935b-232980ea840512016-04-04
63187-455-30EA - Each63187-45561312407-9cab-4cb4-b064-2ff3aa4c80cb12016-01-13
63187-455-60EA - Each63187-455c8c6cd14-3710-4a17-bf59-0a78279798d712015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [PROFICIENT RX LP]2
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [PROFICIENT RX LP]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [PROFICIENT RX LP]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [PROFICIENT RX LP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-455NAPROXEN TABLET [PROFICIENT RX LP]5Current NDC, Legacy NDC, 4 package rows20210114_fc3ee94a-adb7-411e-a662-2f2c6ddbabaf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSNfc3ee94a-adb7-411e-a662-2f2c6ddbabaf5
198014naproxen 500 MG Oral TabletSCDfc3ee94a-adb7-411e-a662-2f2c6ddbabaf5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-455-206318704552020 TABLET in 1 BOTTLE (63187-455-20) 20 tablet2019-01-010000-00-00NoNoCurrent
63187-455-306318704553030 TABLET in 1 BOTTLE (63187-455-30) 30 tablet2019-01-010000-00-00NoNoCurrent
63187-455-606318704556060 TABLET in 1 BOTTLE (63187-455-60) 60 tablet2019-01-010000-00-00NoNoCurrent
63187-455-906318704559090 TABLET in 1 BOTTLE (63187-455-90) 90 tablet2019-01-010000-00-00NoNoCurrent