FDA.reportPublic FDA data

Naproxen

Product NDC
50844-261
11-digit product format
508440261
Labeler code
50844
Product ID
50844-261_f5f6ef48-fa2a-4a62-9cde-0a685fe575b0
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L.N.K. International, Inc.
Application
ANDA204872
Marketing category
ANDA
Marketing start
2019-08-06
Substance
NAPROXEN SODIUM
Active strength
220 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Naproxen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN SODIUM220 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9TN87S3A3C
Rxcui849574

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50844-261-08Naproxen1 in 1 CARTONTABLET, FILM COATED110
50844-261-08Naproxen24 in 1 BOTTLE, PLASTICTABLET, FILM COATED2410

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50844-261NAPROXEN (NAPROXEN SODIUM) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]9Current NDC, Legacy NDC, 2 package rows20240825_82412133-c11a-4905-a119-965f44de10b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN82412133-c11a-4905-a119-965f44de10b710
849574naproxen sodium 220 MG Oral TabletSCD82412133-c11a-4905-a119-965f44de10b710
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY82412133-c11a-4905-a119-965f44de10b710

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50844-261-08508440261081 BOTTLE, PLASTIC in 1 CARTON (50844-261-08) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2019-08-060000-00-00NoNoCurrent