Naproxen Sodium

Product NDC
63940-761
11-digit product format
639400761
Labeler code
63940
Product ID
63940-761_99eb0620-baf1-5fa1-e053-2a95a90a03d9
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
HARMON STORES INC.
Application
ANDA091353
Marketing category
ANDA
Marketing start
2018-10-01
Marketing end
0000-00-00
Substance
NAPROXEN SODIUM
Active strength
220 mg/1
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
63940-761-052023-01-30C16284748780-1f386c64a-11f7-0266-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
63940-761-05Naproxen Sodium50 in 1 BOTTLETABLET502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63940-761NAPROXEN SODIUM TABLET [HARMON STORES INC.]2Legacy NDC, 1 package rows20191218_76a17f69-0071-e102-e053-2991aa0a3a66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN76a17f69-0071-e102-e053-2991aa0a3a662
849574naproxen sodium 220 MG Oral TabletSCD76a17f69-0071-e102-e053-2991aa0a3a662
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY76a17f69-0071-e102-e053-2991aa0a3a662

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63940-761-056394007610550 TABLET in 1 BOTTLE (63940-761-05) 50 tablet2018-10-010000-00-00NoNoCurrent