Naproxen

Product NDC
50090-3524
11-digit product format
500903524
Labeler code
50090
Product ID
50090-3524_16e519ed-3500-4242-b4ef-dcdce24f0e32
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
2022-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3524-0Naproxen100 in 1 BOTTLETABLET, DELAYED RELEASE1001
50090-3524-0Naproxen24 in 1 CASETABLET, DELAYED RELEASE241

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3524NAPROXEN TABLET, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20210602_f60e3860-dfa7-4154-aa2f-65db740bf097.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311915naproxen 500 MG Delayed Release Oral TabletPSNf60e3860-dfa7-4154-aa2f-65db740bf0971
311915naproxen 500 MG Delayed Release Oral TabletSCDf60e3860-dfa7-4154-aa2f-65db740bf0971
311915naproxen (as naproxen sodium) 500 MG Delayed Release Oral TabletSYf60e3860-dfa7-4154-aa2f-65db740bf0971

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3524-050090352400100 CASE in 1 BOTTLE (50090-3524-0) > 24 TABLET, DELAYED RELEASE in 1 CASE100 case2018-07-300000-00-00NoNoCurrent