FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
11673-764
11-digit product format
116730764
Labeler code
11673
Product ID
11673-764_46532fbb-e0e4-8e66-e063-6394a90a2a2a
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
TARGET CORPORATION
Application
ANDA091353
Marketing category
ANDA
Marketing start
2024-03-01
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
11673-764-05Naproxen Sodium50 in 1 BOTTLETABLET505
11673-764-09Naproxen Sodium90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-764NAPROXEN SODIUM TABLET [TARGET CORPORATION]3Current NDC, 2 package rows20241120_fdb87abd-3176-dd62-e053-6394a90a6fcc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSNfdb87abd-3176-dd62-e053-6394a90a6fcc5
849574naproxen sodium 220 MG Oral TabletSCDfdb87abd-3176-dd62-e053-6394a90a6fcc5
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSYfdb87abd-3176-dd62-e053-6394a90a6fcc5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11673-764-051167307640550 TABLET in 1 BOTTLE (11673-764-05) 50 tablet2024-03-01NoNoHistorical
11673-764-091167307640990 TABLET in 1 BOTTLE (11673-764-09) 90 tablet2024-03-01NoNoHistorical