FDA.reportPublic FDA data

Naproxen

Product NDC
50090-0482
11-digit product format
500900482
Labeler code
50090
Product ID
50090-0482_bbdc5bb5-1bd1-4245-a325-9fa926043b80
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Naproxen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57Y76R9ATQ
Rxcui198012, 198014

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
50090-0482-0Naproxen21 in 1 BOTTLETABLET2141
50090-0482-1Naproxen90 in 1 BOTTLETABLET9041
50090-0482-2Naproxen180 in 1 BOTTLETABLET18041

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0482-1EA - Each50090-0482b786e69c-ddc6-4a18-a413-fd67ed87e57212018-10-11
50090-0482-2EA - Each50090-04822494b1d4-32a0-4395-8f9c-10cad4da2be612018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0482NAPROXEN TABLET [A-S MEDICATION SOLUTIONS]39Current NDC, Legacy NDC, 3 package rows20241018_d06db628-f6f0-48e2-b538-69c0837c49e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198012naproxen 375 MG Oral TabletPSNd06db628-f6f0-48e2-b538-69c0837c49e341
198014naproxen 500 MG Oral TabletPSNd06db628-f6f0-48e2-b538-69c0837c49e341
198012naproxen 375 MG Oral TabletSCDd06db628-f6f0-48e2-b538-69c0837c49e341
198014naproxen 500 MG Oral TabletSCDd06db628-f6f0-48e2-b538-69c0837c49e341

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0482-05009004820021 TABLET in 1 BOTTLE (50090-0482-0) 21 tablet2014-11-28NoNoHistorical
50090-0482-15009004820190 TABLET in 1 BOTTLE (50090-0482-1) 90 tablet2018-03-090000-00-00NoNoCurrent
50090-0482-250090048202180 TABLET in 1 BOTTLE (50090-0482-2) 180 tablet2017-12-260000-00-00NoNoCurrent