FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
45865-349
11-digit product format
458650349
Labeler code
45865
Product ID
45865-349_7164427d-38b5-6aae-e053-2995a90a0d07
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA078432
Marketing category
ANDA
Marketing start
2007-04-26
Marketing end
0000-00-00
Substance
NAPROXEN SODIUM
Active strength
550 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
2019-12-31
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
45865-349-302020-01-31C16284748780-19d75b9cf-df97-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. N A P R O X E N SODIUM tablets, for oral use Initial U.S. Approval: 1976
45865-349-602020-01-31C16284748780-19d75b9cf-df97-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. N A P R O X E N SODIUM tablets, for oral use Initial U.S. Approval: 1976
45865-349-902020-01-31C16284748780-19d75b9cf-df97-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. N A P R O X E N SODIUM tablets, for oral use Initial U.S. Approval: 1976

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-349-30Naproxen Sodium30 in 1 BOTTLETABLET301
45865-349-60Naproxen Sodium60 in 1 BOTTLETABLET601
45865-349-90Naproxen Sodium90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-349NAPROXEN SODIUM TABLET [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 3 package rows20180720_7164427d-38b4-6aae-e053-2995a90a0d07.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849431naproxen sodium 550 MG Oral TabletPSN7164427d-38b4-6aae-e053-2995a90a0d071
849431naproxen sodium 550 MG Oral TabletSCD7164427d-38b4-6aae-e053-2995a90a0d071
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY7164427d-38b4-6aae-e053-2995a90a0d071

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
45865-349-304586503493030 in 1 BOTTLEHistorical
45865-349-604586503496060 in 1 BOTTLEHistorical
45865-349-904586503499090 in 1 BOTTLEHistorical