Naproxen

Product NDC
45865-610
11-digit product format
458650610
Labeler code
45865
Product ID
45865-610_9ab33b7d-7094-51b3-e053-2a95a90ad2aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA078250
Marketing category
ANDA
Marketing start
2007-07-01
Marketing end
0000-00-00
Substance
NAPROXEN
Active strength
250 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
45865-610-202025-01-30C16284748780-12cef2736-92d6-d83d-e063-dadaa90ab31fNAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-610-20Naproxen20 in 1 BOTTLETABLET202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-610NAPROXEN TABLET [MEDSOURCE PHARMACEUTICALS]2Legacy NDC, 1 package rows20191228_1f7d2f11-5b62-1c90-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198013naproxen 250 MG Oral TabletPSN1f7d2f11-5b62-1c90-e054-00144ff88e882
198013naproxen 250 MG Oral TabletSCD1f7d2f11-5b62-1c90-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-610-204586506102020 TABLET in 1 BOTTLE (45865-610-20) 20 tablet2015-09-110000-00-00NoNoCurrent