FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
68196-255
11-digit product format
681960255
Labeler code
68196
Product ID
68196-255_8f4b0483-1a09-88f8-d289-faed40edd37c
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, COATED
Route
ORAL
Labeler
SAM'S WEST INC
Application
ANDA075168
Marketing category
ANDA
Marketing start
1998-07-29
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
68196-255-20Naproxen Sodium400 in 1 BOTTLETABLET, COATED4004
68196-255-40Naproxen Sodium400 in 1 BOTTLETABLET, COATED4004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-255NAPROXEN SODIUM TABLET, COATED [SAM'S WEST INC]3Current NDC, Legacy NDC, 2 package rows20250308_7a87a339-4482-ec9e-3c77-7ccb9cea2c4c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN7a87a339-4482-ec9e-3c77-7ccb9cea2c4c4
849574naproxen sodium 220 MG Oral TabletSCD7a87a339-4482-ec9e-3c77-7ccb9cea2c4c4
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY7a87a339-4482-ec9e-3c77-7ccb9cea2c4c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68196-255-2068196025520400 TABLET, COATED in 1 BOTTLE (68196-255-20) 2023-03-01NoNoCurrent
68196-255-4068196025540400 TABLET, COATED in 1 BOTTLE (68196-255-40) 2025-05-01NoNoCurrent