Naproxen Sodium

Product NDC
53808-0742
11-digit product format
538080742
Labeler code
53808
Product ID
53808-0742_e46640dd-311d-4e68-9424-7c4c7ade7847
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NAPROXEN SODIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA074201
Marketing category
ANDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
NAPROXEN SODIUM
Active strength
550 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
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
53808-0742-12020-01-31C16284748780-19d75b9d0-0106-f424-e053-dadaa90a57ceNAPROXEN SODIUM TABLETS USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0742-1Naproxen Sodium30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0742NAPROXEN SODIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100611_5d85fd0c-c544-4026-b797-93445ce6ba7e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849431naproxen sodium 550 MG Oral TabletPSN5d85fd0c-c544-4026-b797-93445ce6ba7e1
849431naproxen sodium 550 MG Oral TabletSCD5d85fd0c-c544-4026-b797-93445ce6ba7e1
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY5d85fd0c-c544-4026-b797-93445ce6ba7e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0742-15380807420130 in 1 BLISTER PACKHistorical