FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
37835-594
11-digit product format
378350594
Labeler code
37835
Product ID
37835-594_313c8866-b504-7387-e063-6394a90a197f
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Bi-Mart
Application
ANDA091353
Marketing category
ANDA
Marketing start
2011-09-30
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
37835-594-01Naproxen Sodium100 in 1 BOTTLETABLET1001
37835-594-03Naproxen Sodium300 in 1 BOTTLETABLET3001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37835-594NAPROXEN SODIUM TABLET [BI-MART]1Current NDC, 2 package rows20250330_6d5cecc9-5095-477b-bfc7-45b6e7e689f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN6d5cecc9-5095-477b-bfc7-45b6e7e689f01
849574naproxen sodium 220 MG Oral TabletSCD6d5cecc9-5095-477b-bfc7-45b6e7e689f01
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY6d5cecc9-5095-477b-bfc7-45b6e7e689f01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
37835-594-0137835059401100 TABLET in 1 BOTTLE (37835-594-01) 100 tablet2025-03-01NoNoHistorical
37835-594-0337835059403300 TABLET in 1 BOTTLE (37835-594-03) 300 tablet2025-03-01NoNoHistorical