FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
83324-109
11-digit product format
833240109
Labeler code
83324
Product ID
83324-109_3806291c-fce8-bcac-e063-6294a90ae162
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
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
83324-109-01Naproxen Sodium1 in 1 PACKAGETABLET, COATED13
83324-109-01Naproxen Sodium100 in 1 BOTTLE, PLASTICTABLET, COATED1003
83324-109-50Naproxen Sodium50 in 1 BOTTLE, PLASTICTABLET, COATED503
83324-109-50Naproxen Sodium1 in 1 CARTONTABLET, COATED13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83324-109-50EA - Each83324-10909483eea-3268-45af-b9d3-8a29a2ce637b12025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-109NAPROXEN SODIUM TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION, INC.]2Current NDC, 4 package rows20250522_84b9e9a4-b805-420e-83be-ebe98776d1ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN84b9e9a4-b805-420e-83be-ebe98776d1ee3
849574naproxen sodium 220 MG Oral TabletSCD84b9e9a4-b805-420e-83be-ebe98776d1ee3
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY84b9e9a4-b805-420e-83be-ebe98776d1ee3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83324-109-01833240109011 BOTTLE, PLASTIC in 1 PACKAGE (83324-109-01) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2025-05-20NoNoHistorical
83324-109-50833240109501 BOTTLE, PLASTIC in 1 CARTON (83324-109-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC2025-05-20NoNoHistorical