FDA.reportPublic FDA data

Naproxen

Product NDC
68071-2467
11-digit product format
680712467
Labeler code
68071
Product ID
68071-2467_c6765b1b-d5e4-32fd-e053-2a95a90a6a53
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
Marketing end
0000-00-00
Substance
NAPROXEN
Active strength
500 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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
68071-2467-22025-01-30C16284748780-1f386c649-ae2f-0266-e053-dadaa90a7c1aThese 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
68071-2467-32025-01-30C16284748780-1f386c649-ae2f-0266-e053-dadaa90a7c1aThese 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
68071-2467-42025-01-30C16284748780-1f386c649-ae2f-0266-e053-dadaa90a7c1aThese 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
68071-2467-62025-01-30C16284748780-1f386c649-ae2f-0266-e053-dadaa90a7c1aThese 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
68071-2467-72025-01-30C16284748780-1f386c649-ae2f-0266-e053-dadaa90a7c1aThese 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
68071-2467-92025-01-30C16284748780-1f386c649-ae2f-0266-e053-dadaa90a7c1aThese 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
68071-2467-22023-06-06C16284748780-1f386c649-ae2f-0266-e053-dadaa90a7c1aThese 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
68071-2467-32023-06-06C16284748780-1f386c649-ae2f-0266-e053-dadaa90a7c1aThese 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
68071-2467-42023-06-06C16284748780-1f386c649-ae2f-0266-e053-dadaa90a7c1aThese 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
68071-2467-62023-06-06C16284748780-1f386c649-ae2f-0266-e053-dadaa90a7c1aThese 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
68071-2467-72023-06-06C16284748780-1f386c649-ae2f-0266-e053-dadaa90a7c1aThese 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
68071-2467-22023-01-30C16284748780-1f386c649-ae2f-0266-e053-dadaa90a7c1aThese 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
68071-2467-32023-01-30C16284748780-1f386c649-ae2f-0266-e053-dadaa90a7c1aThese 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
68071-2467-42023-01-30C16284748780-1f386c649-ae2f-0266-e053-dadaa90a7c1aThese 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
68071-2467-62023-01-30C16284748780-1f386c649-ae2f-0266-e053-dadaa90a7c1aThese 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
68071-2467-72023-01-30C16284748780-1f386c649-ae2f-0266-e053-dadaa90a7c1aThese 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
68071-2467-2Naproxen20 in 1 BOTTLETABLET202
68071-2467-3Naproxen30 in 1 BOTTLETABLET302
68071-2467-4Naproxen40 in 1 BOTTLETABLET402
68071-2467-6Naproxen60 in 1 BOTTLETABLET602
68071-2467-7Naproxen14 in 1 BOTTLETABLET142
68071-2467-9Naproxen90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2467NAPROXEN TABLET [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 6 package rows20230608_c6765b1b-d5e3-32fd-e053-2a95a90a6a53.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSNc6765b1b-d5e3-32fd-e053-2a95a90a6a532
198014naproxen 500 MG Oral TabletSCDc6765b1b-d5e3-32fd-e053-2a95a90a6a532

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2467-26807124670220 TABLET in 1 BOTTLE (68071-2467-2) 20 tablet2021-07-060000-00-00NoNoCurrent
68071-2467-36807124670330 TABLET in 1 BOTTLE (68071-2467-3) 30 tablet2021-07-060000-00-00NoNoCurrent
68071-2467-46807124670440 TABLET in 1 BOTTLE (68071-2467-4) 40 tablet2021-07-060000-00-00NoNoCurrent
68071-2467-66807124670660 TABLET in 1 BOTTLE (68071-2467-6) 60 tablet2021-07-060000-00-00NoNoCurrent
68071-2467-76807124670714 TABLET in 1 BOTTLE (68071-2467-7) 14 tablet2021-07-060000-00-00NoNoCurrent
68071-2467-96807124670990 in 1 BOTTLEHistorical