FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
68071-2333
11-digit product format
680712333
Labeler code
68071
Product ID
68071-2333_2ad6c528-4120-6dec-e063-6394a90adfea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA212199
Marketing category
ANDA
Marketing start
2019-10-30
Substance
NAPROXEN SODIUM
Active strength
550 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 SODIUM550 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9TN87S3A3C
Rxcui849431

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2333-42024-12-19C16284748780-1f386c649-fb90-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976
68071-2333-42023-01-30C16284748780-1f386c649-fb90-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2333-2Naproxen Sodium21 in 1 BOTTLETABLET213
68071-2333-3Naproxen Sodium30 in 1 BOTTLETABLET303
68071-2333-4Naproxen Sodium14 in 1 BOTTLETABLET143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2333NAPROXEN SODIUM TABLET [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 3 package rows20250105_b8e417d2-3fc8-9a5e-e053-2a95a90a4155.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849431naproxen sodium 550 MG Oral TabletPSNb8e417d2-3fc8-9a5e-e053-2a95a90a41553
849431naproxen sodium 550 MG Oral TabletSCDb8e417d2-3fc8-9a5e-e053-2a95a90a41553
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSYb8e417d2-3fc8-9a5e-e053-2a95a90a41553

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2333-26807123330221 TABLET in 1 BOTTLE (68071-2333-2) 21 tablet2024-12-19NoNoCurrent
68071-2333-36807123330330 TABLET in 1 BOTTLE (68071-2333-3) 30 tablet2021-01-14NoNoCurrent
68071-2333-46807123330414 TABLET in 1 BOTTLE (68071-2333-4) 14 tablet2021-01-140000-00-00NoNoCurrent