FDA.reportPublic FDA data

Naproxen

Product NDC
50090-1583
11-digit product format
500901583
Labeler code
50090
Product ID
50090-1583_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
375 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
NAPROXEN375 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1583-22023-02-07C16284748780-1f386c64a-4a2d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS. NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS for oral use Initial U.S. Approval: 1976
50090-1583-42023-02-07C16284748780-1f386c64a-4a2d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS. NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS for oral use Initial U.S. Approval: 1976
50090-1583-82023-02-07C16284748780-1f386c64a-4a2d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS. NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS for oral use Initial U.S. Approval: 1976
50090-1583-22023-01-30C16284748780-1f386c64a-4a2d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS. NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS for oral use Initial U.S. Approval: 1976
50090-1583-42023-01-30C16284748780-1f386c64a-4a2d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS. NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS for oral use Initial U.S. Approval: 1976
50090-1583-82023-01-30C16284748780-1f386c64a-4a2d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS. NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS for oral use Initial U.S. Approval: 1976

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1583-2Naproxen30 in 1 BOTTLETABLET3041
50090-1583-4Naproxen20 in 1 BOTTLETABLET2041
50090-1583-8Naproxen100 in 1 BOTTLETABLET10041

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1583-2EA - Each50090-1583656b7155-6d2f-4b06-b214-fd68ebca33a112018-11-06
50090-1583-4EA - Each50090-1583daa13500-11cc-460a-b0a6-b1d3701a23d912018-08-13
50090-1583-8EA - Each50090-1583cebb4cac-f56e-4be1-8308-26d04fe3d9fb12018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1583NAPROXEN 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
50090-1583-25009015830230 TABLET in 1 BOTTLE (50090-1583-2) 30 tablet2014-12-290000-00-00NoNoCurrent
50090-1583-45009015830420 TABLET in 1 BOTTLE (50090-1583-4) 20 tablet2014-12-290000-00-00NoNoCurrent
50090-1583-850090158308100 TABLET in 1 BOTTLE (50090-1583-8) 100 tablet2014-12-290000-00-00NoNoCurrent