FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
50844-604
11-digit product format
508440604
Labeler code
50844
Product ID
50844-604_89d3ed35-e75c-41d8-aa99-57cc1fd866d2
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
2017-02-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Naproxen Sodium
Listing expiration
2027-12-31

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
50844-604-06Naproxen Sodium200 in 1 BOTTLE, PLASTICTABLET, FILM COATED20015
50844-604-09Naproxen Sodium4 in 1 CARTONTABLET, FILM COATED415
50844-604-09Naproxen Sodium5 in 1 BLISTER PACKTABLET, FILM COATED515
50844-604-14Naproxen Sodium500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50015
50844-604-15Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED115
50844-604-15Naproxen Sodium50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5015
50844-604-16Naproxen Sodium1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED100015
50844-604-19Naproxen Sodium8 in 1 BOTTLE, PLASTICTABLET, FILM COATED815
50844-604-19Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED115
50844-604-56Naproxen Sodium25 in 1 BOTTLE, PLASTICTABLET, FILM COATED2515
50844-604-98Naproxen Sodium8 in 1 BOTTLE, PLASTICTABLET, FILM COATED815
50844-604-99Naproxen Sodium8 in 1 BOTTLE, PLASTICTABLET, FILM COATED815

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50844-604NAPROXEN SODIUM TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]13Current NDC, Legacy NDC, 12 package rows20250116_717518e4-2537-4229-b765-c6acfe963d4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN717518e4-2537-4229-b765-c6acfe963d4b15
849574naproxen sodium 220 MG Oral TabletSCD717518e4-2537-4229-b765-c6acfe963d4b15
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY717518e4-2537-4229-b765-c6acfe963d4b15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50844-604-0650844060406200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-604-06) 2026-02-19NoNoCurrent
50844-604-09508440604094 BLISTER PACK in 1 CARTON (50844-604-09) / 5 TABLET, FILM COATED in 1 BLISTER PACK4 blister pack2017-02-010000-00-00NoNoCurrent
50844-604-1450844060414500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-604-14) 2017-02-010000-00-00NoNoCurrent
50844-604-15508440604151 BOTTLE, PLASTIC in 1 CARTON (50844-604-15) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2017-02-01NoNoCurrent
50844-604-16508440604161000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-604-16) 2017-02-010000-00-00NoNoCurrent
50844-604-19508440604191 BOTTLE, PLASTIC in 1 CARTON (50844-604-19) / 8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2017-02-010000-00-00NoNoCurrent
50844-604-565084406045625 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-604-56) 2017-02-010000-00-00NoNoCurrent
50844-604-98508440604988 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-604-98) 2017-02-010000-00-00NoNoCurrent
50844-604-99508440604998 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-604-99) 2017-02-010000-00-00NoNoCurrent