FDA.reportPublic FDA data

Naproxen Sodium 220mg

Product NDC
69197-394
11-digit product format
691970394
Labeler code
69197
Product ID
69197-394_3441a647-8818-4c13-9ba8-6a012e46b508
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium 220mg
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Command Brands, LLC
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 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
69197-394-24Naproxen Sodium 220mg1 in 1 CARTONTABLET, COATED11
69197-394-24Naproxen Sodium 220mg24 in 1 BOTTLETABLET, COATED241

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69197-394NAPROXEN SODIUM 220MG TABLET, COATED [COMMAND BRANDS, LLC]1Current NDC, Legacy NDC, 2 package rows20181214_002052df-83ac-4efd-926c-b60a8f64cec4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN002052df-83ac-4efd-926c-b60a8f64cec41
849574naproxen sodium 220 MG Oral TabletSCD002052df-83ac-4efd-926c-b60a8f64cec41
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY002052df-83ac-4efd-926c-b60a8f64cec41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69197-394-24691970394241 BOTTLE in 1 CARTON (69197-394-24) / 24 TABLET, COATED in 1 BOTTLE1 bottle2014-12-230000-00-00NoNoCurrent