FDA.reportPublic FDA data

Naproxen

Product NDC
63187-028
11-digit product format
631870028
Labeler code
63187
Product ID
63187-028_e1ba35a9-7bc6-4597-965a-7e9fbd602a9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078250
Marketing category
ANDA
Marketing start
2007-07-01
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
63187-028-10Naproxen10 in 1 BOTTLETABLET1011
63187-028-14Naproxen14 in 1 BOTTLETABLET1411
63187-028-15Naproxen15 in 1 BOTTLETABLET1511
63187-028-20Naproxen20 in 1 BOTTLETABLET2011
63187-028-30Naproxen30 in 1 BOTTLETABLET3011
63187-028-40Naproxen40 in 1 BOTTLETABLET4011
63187-028-45Naproxen45 in 1 BOTTLETABLET4511
63187-028-60Naproxen60 in 1 BOTTLETABLET6011
63187-028-90Naproxen90 in 1 BOTTLETABLET9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-028-10EA - Each63187-0280cab474b-242a-4a94-a420-06459689f0d112019-06-19
63187-028-14EA - Each63187-0288b2c444f-65d1-4f05-9356-a5ff58cf42ee12017-06-15
63187-028-15EA - Each63187-0287e719c79-ce64-44d5-900d-56f679db8dbd12016-04-04
63187-028-20EA - Each63187-028e8898847-f447-43f7-8e23-48ac851ad65e12017-03-06
63187-028-30EA - Each63187-0285a51dd3c-1cb8-4469-9173-d63d89c8003c12015-05-05
63187-028-40EA - Each63187-02818d9fe8c-f6b4-4b23-ab7f-c1d71c1b5ef312017-07-07
63187-028-60EA - Each63187-0288eb4b8fd-f5d4-4089-ba75-4000cb7b0c8412015-03-03
63187-028-90EA - Each63187-02894c4a62e-9616-404d-a88f-9d678bb87fe112023-08-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [PROFICIENT RX LP]4
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [PROFICIENT RX LP]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNAPROXEN TABLET [PROFICIENT RX LP]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [PROFICIENT RX LP]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [PROFICIENT RX LP]4
POVIDONESINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [PROFICIENT RX LP]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-028NAPROXEN TABLET [PROFICIENT RX LP]11Current NDC, Legacy NDC, 9 package rows20220421_96601d76-50ea-4dc0-b588-d174f8d8bb51.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSN96601d76-50ea-4dc0-b588-d174f8d8bb5111
198014naproxen 500 MG Oral TabletSCD96601d76-50ea-4dc0-b588-d174f8d8bb5111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-028-106318700281010 TABLET in 1 BOTTLE (63187-028-10) 10 tablet2019-03-010000-00-00NoNoCurrent
63187-028-146318700281414 TABLET in 1 BOTTLE (63187-028-14) 14 tablet2017-05-010000-00-00NoNoCurrent
63187-028-156318700281515 TABLET in 1 BOTTLE (63187-028-15) 15 tablet2014-05-010000-00-00NoNoCurrent
63187-028-206318700282020 TABLET in 1 BOTTLE (63187-028-20) 20 tablet2014-05-010000-00-00NoNoCurrent
63187-028-306318700283030 TABLET in 1 BOTTLE (63187-028-30) 30 tablet2014-05-010000-00-00NoNoCurrent
63187-028-406318700284040 TABLET in 1 BOTTLE (63187-028-40) 40 tablet2017-06-010000-00-00NoNoCurrent
63187-028-456318700284545 TABLET in 1 BOTTLE (63187-028-45) 45 tablet2014-05-010000-00-00NoNoCurrent
63187-028-606318700286060 TABLET in 1 BOTTLE (63187-028-60) 60 tablet2014-05-010000-00-00NoNoCurrent
63187-028-906318700289090 TABLET in 1 BOTTLE (63187-028-90) 90 tablet2014-05-010000-00-00NoNoCurrent