Naproxen Sodium

Product NDC
50090-5538
11-digit product format
500905538
Labeler code
50090
Product ID
50090-5538_69755bb4-bf12-4b74-87ea-4c54d6e26b89
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091353
Marketing category
ANDA
Marketing start
2019-07-01
Marketing end
0000-00-00
Substance
NAPROXEN SODIUM
Active strength
220 mg/1
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5538-12023-01-30C16284748780-1f386c649-bc47-0266-e053-dadaa90a7c1aNaproxen Sodium Tablets, USP 220 mg (NSAID)** Pain reliever/fever reducer STRENGTH TO LAST 12 HOURS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5538-1Naproxen Sodium10 in 1 BOTTLETABLET101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5538NAPROXEN SODIUM TABLET [A-S MEDICATION SOLUTIONS]1Legacy NDC, 1 package rows20210513_a7477886-7beb-45e1-93fd-ba06e4a7f0cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSNa7477886-7beb-45e1-93fd-ba06e4a7f0cb1
849574naproxen sodium 220 MG Oral TabletSCDa7477886-7beb-45e1-93fd-ba06e4a7f0cb1
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSYa7477886-7beb-45e1-93fd-ba06e4a7f0cb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5538-15009055380110 TABLET in 1 BOTTLE (50090-5538-1) 10 tablet2021-05-060000-00-00NoNoCurrent