FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
58602-845
11-digit product format
586020845
Labeler code
58602
Product ID
58602-845_58b5f12c-9192-4b1a-8fe7-a9b039f909ac
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA205497
Marketing category
ANDA
Marketing start
2020-05-16
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
58602-845-21Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED15
58602-845-21Naproxen Sodium100 in 1 BOTTLETABLET, FILM COATED1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-845NAPROXEN SODIUM TABLET, FILM COATED [AUROHEALTH LLC]5Current NDC, Legacy NDC, 2 package rows20250524_d570f8f3-88b8-408d-8d20-3ca5f64c81f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSNd570f8f3-88b8-408d-8d20-3ca5f64c81f85
849574naproxen sodium 220 MG Oral TabletSCDd570f8f3-88b8-408d-8d20-3ca5f64c81f85
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSYd570f8f3-88b8-408d-8d20-3ca5f64c81f85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-845-21586020845211 BOTTLE in 1 CARTON (58602-845-21) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-05-160000-00-00NoNoCurrent