naproxen sodium

Product NDC
37808-631
11-digit product format
378080631
Labeler code
37808
Product ID
37808-631_9f36795c-d329-4ef5-9eff-b65080ae9dd7
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
naproxen sodium
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
37808-631-82naproxen sodium200 in 1 BOTTLETABLET, FILM COATED2006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-631NAPROXEN SODIUM TABLET, FILM COATED [H E B]6Current NDC, Legacy NDC, 1 package rows20240426_535a6531-3372-4206-b97b-f26a16b6d80c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN535a6531-3372-4206-b97b-f26a16b6d80c6
849574naproxen sodium 220 MG Oral TabletSCD535a6531-3372-4206-b97b-f26a16b6d80c6
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY535a6531-3372-4206-b97b-f26a16b6d80c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
37808-631-8237808063182200 TABLET, FILM COATED in 1 BOTTLE (37808-631-82) 2017-11-140000-00-00NoNoCurrent