FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
83324-108
11-digit product format
833240108
Labeler code
83324
Product ID
83324-108_3593ed8b-e442-830c-e063-6294a90a7afb
Type
HUMAN OTC DRUG
Nonproprietary name
NAPROXEN SODIUM
Dosage form
TABLET, COATED
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION, INC.
Application
ANDA079096
Marketing category
ANDA
Marketing start
2025-05-20
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
83324-108-01Naproxen Sodium1 in 1 CARTONTABLET, COATED12
83324-108-01Naproxen Sodium100 in 1 BOTTLE, PLASTICTABLET, COATED1002
83324-108-24Naproxen Sodium24 in 1 BOTTLE, PLASTICTABLET, COATED242
83324-108-24Naproxen Sodium1 in 1 CARTONTABLET, COATED12
83324-108-50Naproxen Sodium50 in 1 BOTTLE, PLASTICTABLET, COATED502
83324-108-50Naproxen Sodium1 in 1 CARTONTABLET, COATED12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83324-108-50EA - Each83324-10808de4783-dc31-4ec4-b4e3-812ab8b69bd212025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-108NAPROXEN SODIUM TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION, INC.]2Current NDC, 6 package rows20250522_04245a78-228e-439f-8ffb-9d9bc56c7bb7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN04245a78-228e-439f-8ffb-9d9bc56c7bb72
849574naproxen sodium 220 MG Oral TabletSCD04245a78-228e-439f-8ffb-9d9bc56c7bb72
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY04245a78-228e-439f-8ffb-9d9bc56c7bb72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83324-108-01833240108011 BOTTLE, PLASTIC in 1 CARTON (83324-108-01) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2025-05-20NoNoHistorical
83324-108-24833240108241 BOTTLE, PLASTIC in 1 CARTON (83324-108-24) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC2025-05-20NoNoHistorical
83324-108-50833240108501 BOTTLE, PLASTIC in 1 CARTON (83324-108-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC2025-05-20NoNoHistorical