FDA.reportPublic FDA data

Naproxen

Product NDC
52959-191
11-digit product format
529590191
Labeler code
52959
Product ID
52959-191_e0716b0d-f797-4807-a4ef-81e8262b246f
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
Active strength
375 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
52959-191-002019-11-13C16284748780-197449f38-d136-f6ea-e053-dbdaa90aa703Naproxen Tablets, USP Naproxen Sodium Tablets, USP
52959-191-102019-11-13C16284748780-197449f38-d136-f6ea-e053-dbdaa90aa703Naproxen Tablets, USP Naproxen Sodium Tablets, USP
52959-191-142019-11-13C16284748780-197449f38-d136-f6ea-e053-dbdaa90aa703Naproxen Tablets, USP Naproxen Sodium Tablets, USP
52959-191-152019-11-13C16284748780-197449f38-d136-f6ea-e053-dbdaa90aa703Naproxen Tablets, USP Naproxen Sodium Tablets, USP
52959-191-202019-11-13C16284748780-197449f38-d136-f6ea-e053-dbdaa90aa703Naproxen Tablets, USP Naproxen Sodium Tablets, USP
52959-191-282019-11-13C16284748780-197449f38-d136-f6ea-e053-dbdaa90aa703Naproxen Tablets, USP Naproxen Sodium Tablets, USP
52959-191-302019-11-13C16284748780-197449f38-d136-f6ea-e053-dbdaa90aa703Naproxen Tablets, USP Naproxen Sodium Tablets, USP
52959-191-402019-11-13C16284748780-197449f38-d136-f6ea-e053-dbdaa90aa703Naproxen Tablets, USP Naproxen Sodium Tablets, USP
52959-191-602019-11-13C16284748780-197449f38-d136-f6ea-e053-dbdaa90aa703Naproxen Tablets, USP Naproxen Sodium Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-191-00Naproxen100 in 1 BOTTLETABLET1001
52959-191-10Naproxen10 in 1 BOTTLETABLET101
52959-191-14Naproxen14 in 1 BOTTLETABLET141
52959-191-15Naproxen15 in 1 BOTTLETABLET151
52959-191-20Naproxen20 in 1 BOTTLETABLET201
52959-191-28Naproxen28 in 1 BOTTLETABLET281
52959-191-30Naproxen30 in 1 BOTTLETABLET301
52959-191-40Naproxen40 in 1 BOTTLETABLET401
52959-191-60Naproxen60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-191-00EA - Each52959-191adb8798c-d0f2-4675-883a-17e60510f86312012-07-24
52959-191-10EA - Each52959-19174711c0a-345c-4a5c-97ea-b4ed058897d812012-07-24
52959-191-14EA - Each52959-191acd94dca-1768-4721-b870-bd8d917f852d12012-07-24
52959-191-15EA - Each52959-1910ec090f5-a92d-4fa7-b907-239f08592ffb12012-07-24
52959-191-20EA - Each52959-1919d4466aa-7606-46f5-bc5a-a6cc87d1f2de12012-07-24
52959-191-28EA - Each52959-1916336af86-c513-44d0-a33d-14158189a1a612012-07-24
52959-191-30EA - Each52959-191e75cde36-fe6c-4394-81b8-50ddcc257f0712012-07-24
52959-191-40EA - Each52959-191f47c40e5-f48c-4305-ab6d-ecff7f302d3b12012-07-24
52959-191-60EA - Each52959-1919037fe4a-4866-4c25-8d95-369a100b246c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [H.J. HARKINS COMPANY, INC.]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [H.J. HARKINS COMPANY, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNAPROXEN TABLET [H.J. HARKINS COMPANY, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [H.J. HARKINS COMPANY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [H.J. HARKINS COMPANY, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [H.J. HARKINS COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-191NAPROXEN TABLET [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 9 package rows20111205_b5331161-8f50-4598-b87d-1bee1e890873.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198012naproxen 375 MG Oral TabletPSNb5331161-8f50-4598-b87d-1bee1e8908731
198012naproxen 375 MG Oral TabletSCDb5331161-8f50-4598-b87d-1bee1e8908731

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-191-0052959019100100 in 1 BOTTLEHistorical
52959-191-105295901911010 in 1 BOTTLEHistorical
52959-191-145295901911414 in 1 BOTTLEHistorical
52959-191-155295901911515 in 1 BOTTLEHistorical
52959-191-205295901912020 in 1 BOTTLEHistorical
52959-191-285295901912828 in 1 BOTTLEHistorical
52959-191-305295901913030 in 1 BOTTLEHistorical
52959-191-405295901914040 in 1 BOTTLEHistorical
52959-191-605295901916060 in 1 BOTTLEHistorical