Naproxen Sodium

Product NDC
68016-661
11-digit product format
680160661
Labeler code
68016
Product ID
68016-661_ba16adf1-6f4f-b473-e053-2a95a90a7219
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Pharmacy Valuce Alliance, LLC
Application
ANDA091353
Marketing category
ANDA
Marketing start
2016-02-25
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
68016-661-052023-01-30C16284748780-1f386c649-cbf4-0266-e053-dadaa90a7c1aNaproxen Sodium Tablets USP 220mg (Round)
68016-661-102023-01-30C16284748780-1f386c649-cbf4-0266-e053-dadaa90a7c1aNaproxen Sodium Tablets USP 220mg (Round)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-661-05Naproxen Sodium50 in 1 BOTTLETABLET504
68016-661-10Naproxen Sodium100 in 1 BOTTLETABLET1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-661-05EA - Each68016-661c59ebbb4-2f0d-4183-8bbd-0c089bbfcb6812022-06-06
68016-661-10EA - Each68016-661268ac862-ecfb-4e37-bd68-18fa02818fd112022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-661NAPROXEN SODIUM TABLET [PHARMACY VALUCE ALLIANCE, LLC]4Legacy NDC, 2 package rows20210131_3da8843c-e8bb-164d-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN3da8843c-e8bb-164d-e054-00144ff8d46c4
849574naproxen sodium 220 MG Oral TabletSCD3da8843c-e8bb-164d-e054-00144ff8d46c4
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY3da8843c-e8bb-164d-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-661-056801606610550 TABLET in 1 BOTTLE (68016-661-05) 50 tablet2016-02-250000-00-00NoNoCurrent
68016-661-1068016066110100 TABLET in 1 BOTTLE (68016-661-10) 100 tablet2016-02-250000-00-00NoNoCurrent