Naproxen

Product NDC
53217-262
11-digit product format
532170262
Labeler code
53217
Product ID
53217-262_4560e3d4-7e51-42c7-bd30-46c481a751ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA078250
Marketing category
ANDA
Marketing start
2007-07-01
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
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-262-30Naproxen30 in 1 BOTTLETABLET301
53217-262-60Naproxen60 in 1 BOTTLETABLET601
53217-262-90Naproxen90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-262-30EA - Each53217-262977819cc-8e02-4efa-8a54-dcee52424a3512017-04-05
53217-262-60EA - Each53217-262410870dc-8810-48f5-b7a0-075ed413879112017-04-05
53217-262-90EA - Each53217-26292dac969-d6af-493c-8259-68c13c98ee1a12017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-262NAPROXEN TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 3 package rows20170313_26105acc-4025-4bcd-b484-1d87609bd7b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198012naproxen 375 MG Oral TabletPSN26105acc-4025-4bcd-b484-1d87609bd7b61
198012naproxen 375 MG Oral TabletSCD26105acc-4025-4bcd-b484-1d87609bd7b61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-262-305321702623030 in 1 BOTTLEHistorical
53217-262-605321702626060 in 1 BOTTLEHistorical
53217-262-905321702629090 in 1 BOTTLEHistorical