FDA.reportPublic FDA data

NAPROXEN

Product NDC
53943-145
11-digit product format
539430145
Labeler code
53943
Product ID
53943-145_35316cb3-d33d-81c6-e063-6294a90a8380
Type
HUMAN OTC DRUG
Nonproprietary name
NAPROXEN SODIUM
Dosage form
TABLET, COATED
Route
ORAL
Labeler
DISCOUNT DRUG MART
Application
ANDA079096
Marketing category
ANDA
Marketing start
2014-10-28
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
53943-145-02NAPROXEN50 in 1 BOTTLE, PLASTICTABLET, COATED503
53943-145-02NAPROXEN1 in 1 CARTONTABLET, COATED13
53943-145-03NAPROXEN1 in 1 CARTONTABLET, COATED13
53943-145-03NAPROXEN100 in 1 BOTTLE, PLASTICTABLET, COATED1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-145NAPROXEN (NAPROXEN SODIUM) TABLET, COATED [DISCOUNT DRUG MART]3Current NDC, Legacy NDC, 4 package rows20250519_a0c67043-1e78-4eac-86e6-497b4364651a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSNa0c67043-1e78-4eac-86e6-497b4364651a3
849574naproxen sodium 220 MG Oral TabletSCDa0c67043-1e78-4eac-86e6-497b4364651a3
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSYa0c67043-1e78-4eac-86e6-497b4364651a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53943-145-02539430145021 BOTTLE, PLASTIC in 1 CARTON (53943-145-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC2014-10-280000-00-00NoNoCurrent
53943-145-03539430145031 BOTTLE, PLASTIC in 1 CARTON (53943-145-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2014-10-280000-00-00NoNoCurrent