FDA.reportPublic FDA data

Naproxen

Product NDC
45865-914
11-digit product format
458650914
Labeler code
45865
Product ID
45865-914_9ab4a961-c408-cc92-e053-2a95a90a56bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
medsource pharmaceuticals
Application
ANDA075227
Marketing category
ANDA
Marketing start
1998-07-31
Marketing end
0000-00-00
Substance
NAPROXEN
Active strength
375 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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
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
45865-914-302023-01-30C16284748780-1f386c64a-2e72-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for NAPROXEN DELAYED-RELEASE TABLETS. NAPROXEN delayed-release tablets, for oral use Initial U.S. Approval: 1976
45865-914-512023-01-30C16284748780-1f386c64a-2e72-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for NAPROXEN DELAYED-RELEASE TABLETS. NAPROXEN delayed-release tablets, for oral use Initial U.S. Approval: 1976
45865-914-602023-01-30C16284748780-1f386c64a-2e72-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for NAPROXEN DELAYED-RELEASE TABLETS. NAPROXEN delayed-release tablets, for oral use Initial U.S. Approval: 1976

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-914-30Naproxen30 in 1 BOTTLETABLET, DELAYED RELEASE302
45865-914-51Naproxen120 in 1 BOTTLETABLET, DELAYED RELEASE1202
45865-914-60Naproxen60 in 1 BOTTLETABLET, DELAYED RELEASE602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-914NAPROXEN TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]2Legacy NDC, 3 package rows20191228_7df1152f-50c0-0571-e053-2991aa0a4437.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
603103naproxen 375 MG Delayed Release Oral TabletPSN7df1152f-50c0-0571-e053-2991aa0a44372
603103naproxen 375 MG Delayed Release Oral TabletSCD7df1152f-50c0-0571-e053-2991aa0a44372
603103naproxen 375 MG (as naproxen sodium 413 MG) Delayed Release Oral TabletSY7df1152f-50c0-0571-e053-2991aa0a44372

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-914-304586509143030 TABLET, DELAYED RELEASE in 1 BOTTLE (45865-914-30) 2018-06-010000-00-00NoNoCurrent
45865-914-5145865091451120 TABLET, DELAYED RELEASE in 1 BOTTLE (45865-914-51) 2018-06-010000-00-00NoNoCurrent
45865-914-604586509146060 TABLET, DELAYED RELEASE in 1 BOTTLE (45865-914-60) 2018-06-010000-00-00NoNoCurrent