NAPROXEN

Product NDC
45865-581
11-digit product format
458650581
Labeler code
45865
Product ID
45865-581_7d634e58-bdb2-14b0-e053-2a91aa0a50d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NAPROXEN
Dosage form
TABLET
Route
ORAL
Labeler
medsource pharmaceuticals
Application
ANDA091416
Marketing category
ANDA
Marketing start
2016-07-06
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
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-581-30NAPROXEN30 in 1 BOTTLE, PLASTICTABLET301
45865-581-60NAPROXEN60 in 1 BOTTLE, PLASTICTABLET601
45865-581-90NAPROXEN90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-581NAPROXEN TABLET [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 3 package rows20181220_7d634e58-bdb1-14b0-e053-2a91aa0a50d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSN7d634e58-bdb1-14b0-e053-2a91aa0a50d91
198014naproxen 500 MG Oral TabletSCD7d634e58-bdb1-14b0-e053-2a91aa0a50d91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-581-304586505813030 TABLET in 1 BOTTLE, PLASTIC (45865-581-30) 30 tablet2018-06-010000-00-00NoNoCurrent
45865-581-604586505816060 TABLET in 1 BOTTLE, PLASTIC (45865-581-60) 60 tablet2018-06-010000-00-00NoNoCurrent
45865-581-904586505819090 TABLET in 1 BOTTLE, PLASTIC (45865-581-90) 90 tablet2018-06-010000-00-00NoNoCurrent