FDA.reportPublic FDA data

naproxen sodium

Product NDC
37808-652
11-digit product format
378080652
Labeler code
37808
Product ID
37808-652_2892644f-e31b-4537-80b5-952a35e9d6cc
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H E B
Application
ANDA074661
Marketing category
ANDA
Marketing start
2017-11-14
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
37808-652-62naproxen sodium1 in 1 CARTONTABLET, FILM COATED16
37808-652-62naproxen sodium24 in 1 BOTTLETABLET, FILM COATED246
37808-652-71naproxen sodium1 in 1 CARTONTABLET, FILM COATED16
37808-652-71naproxen sodium50 in 1 BOTTLETABLET, FILM COATED506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-652NAPROXEN SODIUM TABLET, FILM COATED [H E B]5Current NDC, Legacy NDC, 4 package rows20250306_2f9439bb-e808-4c54-ba61-f75f117c8b37.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN2f9439bb-e808-4c54-ba61-f75f117c8b376
849574naproxen sodium 220 MG Oral TabletSCD2f9439bb-e808-4c54-ba61-f75f117c8b376
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY2f9439bb-e808-4c54-ba61-f75f117c8b376

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-652-62378080652621 BOTTLE in 1 CARTON (37808-652-62) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-11-140000-00-00NoNoCurrent
37808-652-71378080652711 BOTTLE in 1 CARTON (37808-652-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-11-140000-00-00NoNoCurrent