Naproxen

Product NDC
61010-4410
11-digit product format
610104410
Labeler code
61010
Product ID
61010-4410_f8ad2d5e-1cc7-46b3-8579-21bedd2c5d6e
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Safetec of America, Inc.
Application
ANDA091353
Marketing category
ANDA
Marketing start
2020-01-20
Marketing end
0000-00-00
Substance
NAPROXEN SODIUM
Active strength
220 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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
61010-4410-0Naproxen1 in 1 POUCHTABLET12
61010-4410-1Naproxen50 in 1 CARTONTABLET502
61010-4410-2Naproxen100 in 1 CARTONTABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-4410NAPROXEN (NAPROXEN SODIUM) TABLET [SAFETEC OF AMERICA, INC.]2Legacy NDC, 3 package rows20200125_287a381a-df7e-4e93-b097-1efde8a5f120.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN287a381a-df7e-4e93-b097-1efde8a5f1202
849574naproxen sodium 220 MG Oral TabletSCD287a381a-df7e-4e93-b097-1efde8a5f1202
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY287a381a-df7e-4e93-b097-1efde8a5f1202

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61010-4410-0610104410001 TABLET in 1 POUCH (61010-4410-0) 1 tablet2020-01-200000-00-00NoNoCurrent
61010-4410-16101044100150 POUCH in 1 CARTON (61010-4410-1) > 1 TABLET in 1 POUCH (61010-4410-0) 50 pouch2020-01-200000-00-00NoNoCurrent
61010-4410-261010441002100 POUCH in 1 CARTON (61010-4410-2) > 1 TABLET in 1 POUCH (61010-4410-0) 100 pouch2020-01-200000-00-00NoNoCurrent