Naproxen Sodium

Product NDC
55319-761
11-digit product format
553190761
Labeler code
55319
Product ID
55319-761_ba16adf1-6f52-b473-e053-2a95a90a7219
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
FAMILY DOLLAR
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
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
55319-761-05Naproxen Sodium50 in 1 BOTTLETABLET503
55319-761-07Naproxen Sodium15 in 1 BOTTLETABLET153
55319-761-10Naproxen Sodium100 in 1 BOTTLETABLET1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-761NAPROXEN SODIUM TABLET [FAMILY DOLLAR]3Legacy NDC, 3 package rows20210131_76cb050c-dd11-ff4d-e053-2991aa0a6600.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN76cb050c-dd11-ff4d-e053-2991aa0a66003
849574naproxen sodium 220 MG Oral TabletSCD76cb050c-dd11-ff4d-e053-2991aa0a66003
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY76cb050c-dd11-ff4d-e053-2991aa0a66003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55319-761-055531907610550 TABLET in 1 BOTTLE (55319-761-05) 50 tablet2018-10-010000-00-00NoNoCurrent
55319-761-075531907610715 TABLET in 1 BOTTLE (55319-761-07) 15 tablet2019-10-310000-00-00NoNoCurrent
55319-761-1055319076110100 TABLET in 1 BOTTLE (55319-761-10) 100 tablet2018-10-010000-00-00NoNoCurrent