FDA.reportPublic FDA data

Naproxen Sodium 220mg

Product NDC
69168-395
11-digit product format
691680395
Labeler code
69168
Product ID
69168-395_08dc5597-5820-47c7-aec4-72336b5b7089
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium 220mg
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Allegiant Health
Application
ANDA090545
Marketing category
ANDA
Marketing start
2011-05-04
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 220mg
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
69168-395-07Naproxen Sodium 220mg10 in 1 BOTTLETABLET, COATED109
69168-395-17Naproxen Sodium 220mg300 in 1 BOTTLETABLET, COATED3009
69168-395-50Naproxen Sodium 220mg50 in 1 BOTTLETABLET, COATED509

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-395NAPROXEN SODIUM 220MG TABLET, COATED [ALLEGIANT HEALTH]9Current NDC, Legacy NDC, 3 package rows20230519_14554f05-14e1-4c52-99ce-94561c42c0da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN14554f05-14e1-4c52-99ce-94561c42c0da9
849574naproxen sodium 220 MG Oral TabletSCD14554f05-14e1-4c52-99ce-94561c42c0da9
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY14554f05-14e1-4c52-99ce-94561c42c0da9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69168-395-076916803950710 TABLET, COATED in 1 BOTTLE (69168-395-07) 2011-05-04NoNoCurrent
69168-395-1769168039517300 TABLET, COATED in 1 BOTTLE (69168-395-17) 2021-04-210000-00-00NoNoCurrent
69168-395-506916803955050 TABLET, COATED in 1 BOTTLE (69168-395-50) 2022-05-180000-00-00NoNoCurrent