Naproxen Sodium 220mg

Product NDC
53329-688
11-digit product format
533290688
Labeler code
53329
Product ID
53329-688_2876e756-1812-62d6-e063-6394a90a4a0d
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Medline Industries, LP
Application
ANDA090545
Marketing category
ANDA
Marketing start
2018-08-01
Marketing end
2026-06-30
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

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
53329-688-30Naproxen Sodium 220mg100 in 1 BOTTLETABLET1007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-688NAPROXEN SODIUM 220MG (NAPROXEN SODIUM) TABLET [MEDLINE INDUSTRIES, LP]7Current NDC, Legacy NDC, 1 package rows20241207_6d9b3581-63b5-699e-e053-2991aa0a68f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN6d9b3581-63b5-699e-e053-2991aa0a68f87
849574naproxen sodium 220 MG Oral TabletSCD6d9b3581-63b5-699e-e053-2991aa0a68f87
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY6d9b3581-63b5-699e-e053-2991aa0a68f87

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-688-3053329068830100 TABLET in 1 BOTTLE (53329-688-30) 100 tablet2018-08-010000-00-00NoNoCurrent