FDA.reportPublic FDA data

Naproxen

Product NDC
50090-3025
11-digit product format
500903025
Labeler code
50090
Product ID
50090-3025_7b35dd57-ad07-4b3e-bc26-3a2893a6439d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091432
Marketing category
ANDA
Marketing start
2016-07-05
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
2020-12-31
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
50090-3025-02023-01-30C16284748780-1f386c649-b4ef-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for NAPROXEN DELAYED-RELEASE TABLETS. NAPROXEN delayed-release tablets, for oral use Initial U.S. Approval: 1976
50090-3025-12023-01-30C16284748780-1f386c649-b4ef-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for NAPROXEN DELAYED-RELEASE TABLETS. NAPROXEN delayed-release tablets, for oral use Initial U.S. Approval: 1976
50090-3025-32023-01-30C16284748780-1f386c649-b4ef-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for NAPROXEN DELAYED-RELEASE TABLETS. NAPROXEN delayed-release tablets, for oral use Initial U.S. Approval: 1976

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3025-0Naproxen15 in 1 BOTTLETABLET, DELAYED RELEASE153
50090-3025-1Naproxen30 in 1 BOTTLETABLET, DELAYED RELEASE303
50090-3025-3Naproxen60 in 1 BOTTLETABLET, DELAYED RELEASE603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3025NAPROXEN TABLET, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]3Legacy NDC, 3 package rows20191127_5f51e6ed-82dd-450e-9e39-cb11a853bc74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311915naproxen 500 MG Delayed Release Oral TabletPSN5f51e6ed-82dd-450e-9e39-cb11a853bc743
311915naproxen 500 MG Delayed Release Oral TabletSCD5f51e6ed-82dd-450e-9e39-cb11a853bc743
311915naproxen (as naproxen sodium) 500 MG Delayed Release Oral TabletSY5f51e6ed-82dd-450e-9e39-cb11a853bc743

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3025-05009030250015 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-3025-0) 2017-06-120000-00-00NoNoCurrent
50090-3025-15009030250130 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-3025-1) 2017-06-300000-00-00NoNoCurrent
50090-3025-35009030250360 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-3025-3) 2017-05-250000-00-00NoNoCurrent