FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
52959-271
11-digit product format
529590271
Labeler code
52959
Product ID
52959-271_454a1424-a79e-4678-b54f-ea82d88a123e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA078250
Marketing category
ANDA
Marketing start
2007-07-01
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
2017-12-31
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
52959-271-022019-11-13C16284748780-197449f38-b7e3-f6ea-e053-dbdaa90aa703NAPROXEN tablet NAPROXEN SODIUM tablet [H.J. Harkins Company Inc., USA]
52959-271-102019-11-13C16284748780-197449f38-b7e3-f6ea-e053-dbdaa90aa703NAPROXEN tablet NAPROXEN SODIUM tablet [H.J. Harkins Company Inc., USA]
52959-271-142019-11-13C16284748780-197449f38-b7e3-f6ea-e053-dbdaa90aa703NAPROXEN tablet NAPROXEN SODIUM tablet [H.J. Harkins Company Inc., USA]
52959-271-152019-11-13C16284748780-197449f38-b7e3-f6ea-e053-dbdaa90aa703NAPROXEN tablet NAPROXEN SODIUM tablet [H.J. Harkins Company Inc., USA]
52959-271-202019-11-13C16284748780-197449f38-b7e3-f6ea-e053-dbdaa90aa703NAPROXEN tablet NAPROXEN SODIUM tablet [H.J. Harkins Company Inc., USA]
52959-271-212019-11-13C16284748780-197449f38-b7e3-f6ea-e053-dbdaa90aa703NAPROXEN tablet NAPROXEN SODIUM tablet [H.J. Harkins Company Inc., USA]
52959-271-282019-11-13C16284748780-197449f38-b7e3-f6ea-e053-dbdaa90aa703NAPROXEN tablet NAPROXEN SODIUM tablet [H.J. Harkins Company Inc., USA]
52959-271-302019-11-13C16284748780-197449f38-b7e3-f6ea-e053-dbdaa90aa703NAPROXEN tablet NAPROXEN SODIUM tablet [H.J. Harkins Company Inc., USA]
52959-271-402019-11-13C16284748780-197449f38-b7e3-f6ea-e053-dbdaa90aa703NAPROXEN tablet NAPROXEN SODIUM tablet [H.J. Harkins Company Inc., USA]
52959-271-422019-11-13C16284748780-197449f38-b7e3-f6ea-e053-dbdaa90aa703NAPROXEN tablet NAPROXEN SODIUM tablet [H.J. Harkins Company Inc., USA]
52959-271-602019-11-13C16284748780-197449f38-b7e3-f6ea-e053-dbdaa90aa703NAPROXEN tablet NAPROXEN SODIUM tablet [H.J. Harkins Company Inc., USA]
52959-271-902019-11-13C16284748780-197449f38-b7e3-f6ea-e053-dbdaa90aa703NAPROXEN tablet NAPROXEN SODIUM tablet [H.J. Harkins Company Inc., USA]

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-271-02Naproxen Sodium200 in 1 VIAL, PLASTICTABLET2005
52959-271-10Naproxen Sodium10 in 1 VIAL, PLASTICTABLET105
52959-271-14Naproxen Sodium14 in 1 VIAL, PLASTICTABLET145
52959-271-15Naproxen Sodium15 in 1 VIAL, PLASTICTABLET155
52959-271-20Naproxen Sodium20 in 1 VIAL, PLASTICTABLET205
52959-271-21Naproxen Sodium21 in 1 VIAL, PLASTICTABLET215
52959-271-28Naproxen Sodium28 in 1 VIAL, PLASTICTABLET285
52959-271-30Naproxen Sodium30 in 1 VIAL, PLASTICTABLET305
52959-271-40Naproxen Sodium40 in 1 VIAL, PLASTICTABLET405
52959-271-42Naproxen Sodium42 in 1 VIAL, PLASTICTABLET425
52959-271-60Naproxen Sodium60 in 1 VIAL, PLASTICTABLET605
52959-271-90Naproxen Sodium90 in 1 VIAL, PLASTICTABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-271NAPROXEN SODIUM (NAPROXEN) TABLET [H.J. HARKINS COMPANY, INC.]5Legacy NDC, 12 package rows20120419_96ef2f48-d478-478c-95d0-1c0b986493d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849431naproxen sodium 550 MG Oral TabletPSN96ef2f48-d478-478c-95d0-1c0b986493d15
849431naproxen sodium 550 MG Oral TabletSCD96ef2f48-d478-478c-95d0-1c0b986493d15
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY96ef2f48-d478-478c-95d0-1c0b986493d15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-271-0252959027102200 in 1 VIAL, PLASTICHistorical
52959-271-105295902711010 in 1 VIAL, PLASTICHistorical
52959-271-145295902711414 in 1 VIAL, PLASTICHistorical
52959-271-155295902711515 in 1 VIAL, PLASTICHistorical
52959-271-205295902712020 in 1 VIAL, PLASTICHistorical
52959-271-215295902712121 in 1 VIAL, PLASTICHistorical
52959-271-285295902712828 in 1 VIAL, PLASTICHistorical
52959-271-305295902713030 in 1 VIAL, PLASTICHistorical
52959-271-405295902714040 in 1 VIAL, PLASTICHistorical
52959-271-425295902714242 in 1 VIAL, PLASTICHistorical
52959-271-605295902716060 in 1 VIAL, PLASTICHistorical
52959-271-905295902719090 in 1 VIAL, PLASTICHistorical