FDA.reportPublic FDA data

Naproxen

Product NDC
68071-2396
11-digit product format
680712396
Labeler code
68071
Product ID
68071-2396_4ceca119-d24b-f034-e063-6294a90ac008
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA212517
Marketing category
ANDA
Marketing start
2020-03-01
Substance
NAPROXEN
Active strength
500 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Naproxen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57Y76R9ATQ
Rxcui198014

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
68071-2396-42025-01-30C16284748780-12cef2736-5e71-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
68071-2396-62025-01-30C16284748780-12cef2736-5e71-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2396-4Naproxen4 in 1 BOTTLETABLET43
68071-2396-6Naproxen6 in 1 BOTTLETABLET63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2396NAPROXEN TABLET [NUCARE PHARMACEUTICALS,INC.]2Current NDC, Legacy NDC, 2 package rows20220910_c136cf75-4ad4-8634-e053-2a95a90a53a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSNc136cf75-4ad4-8634-e053-2a95a90a53a43
198014naproxen 500 MG Oral TabletSCDc136cf75-4ad4-8634-e053-2a95a90a53a43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2396-4680712396044 TABLET in 1 BOTTLE (68071-2396-4) 4 tablet2021-04-300000-00-00NoNoCurrent
68071-2396-6680712396066 TABLET in 1 BOTTLE (68071-2396-6) 6 tablet2021-04-300000-00-00NoNoCurrent