Naproxen Sodium

Product NDC
55315-992
11-digit product format
553150992
Labeler code
55315
Product ID
55315-992_54ae55e0-1f35-072e-e054-00144ff88e88
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
FREDS INC
Application
ANDA091353
Marketing category
ANDA
Marketing start
2017-08-17
Marketing end
0000-00-00
Substance
NAPROXEN SODIUM
Active strength
220 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
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
55315-992-05Naproxen Sodium50 in 1 BOTTLETABLET502
55315-992-10Naproxen Sodium100 in 1 BOTTLETABLET1002
55315-992-24Naproxen Sodium24 in 1 BOTTLETABLET242

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55315-992NAPROXEN SODIUM TABLET [FREDS INC]2Legacy NDC, 3 package rows20170817_54232d88-ed83-04da-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN54232d88-ed83-04da-e054-00144ff8d46c2
849574naproxen sodium 220 MG Oral TabletSCD54232d88-ed83-04da-e054-00144ff8d46c2
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY54232d88-ed83-04da-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55315-992-055531509920550 in 1 BOTTLEHistorical
55315-992-1055315099210100 in 1 BOTTLEHistorical
55315-992-245531509922424 in 1 BOTTLEHistorical