Naproxen Caplets

Product NDC
69168-394
11-digit product format
691680394
Labeler code
69168
Product ID
69168-394_f6b88aa9-7608-49e8-9841-2cf702715869
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium 220 mg
Dosage form
TABLET
Route
ORAL
Labeler
Allegiant Health
Application
ANDA090545
Marketing category
ANDA
Marketing start
2014-12-23
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 Caplets
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
69168-394-24Naproxen Caplets24 in 1 BOTTLETABLET243
69168-394-24Naproxen Caplets1 in 1 CARTONTABLET13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-394NAPROXEN CAPLETS (NAPROXEN SODIUM 220 MG) TABLET [ALLEGIANT HEALTH]3Current NDC, Legacy NDC, 2 package rows20210422_07120764-7c33-4c07-9367-40956d970c60.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN07120764-7c33-4c07-9367-40956d970c603
849574naproxen sodium 220 MG Oral TabletSCD07120764-7c33-4c07-9367-40956d970c603
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY07120764-7c33-4c07-9367-40956d970c603

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69168-394-1769168039417300 TABLET in 1 BOTTLE (69168-394-17) 300 tablet2014-12-230000-00-00NoNoCurrent
69168-394-24691680394241 BOTTLE in 1 CARTON (69168-394-24) / 24 TABLET in 1 BOTTLE1 bottle2014-12-230000-00-00NoNoCurrent