FDA.reportPublic FDA data

Naproxen

Product NDC
45865-948
11-digit product format
458650948
Labeler code
45865
Product ID
45865-948_9add85b6-a077-b8dc-e053-2a95a90a28ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
medsource pharmaceuticals
Application
ANDA091432
Marketing category
ANDA
Marketing start
2016-07-05
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
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
45865-948-602025-01-30C16284748780-12cef2736-a0bd-d83d-e063-dadaa90ab31fThese 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
45865-948-60Naproxen60 in 1 BOTTLETABLET, DELAYED RELEASE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-948NAPROXEN TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 1 package rows20191230_9add85b6-a076-b8dc-e053-2a95a90a28ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
603103naproxen 375 MG Delayed Release Oral TabletPSN9add85b6-a076-b8dc-e053-2a95a90a28ed1
603103naproxen 375 MG Delayed Release Oral TabletSCD9add85b6-a076-b8dc-e053-2a95a90a28ed1
603103naproxen 375 MG (as naproxen sodium 413 MG) Delayed Release Oral TabletSY9add85b6-a076-b8dc-e053-2a95a90a28ed1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-948-604586509486060 TABLET, DELAYED RELEASE in 1 BOTTLE (45865-948-60) 2018-12-120000-00-00NoNoCurrent