FDA.reportPublic FDA data

Naproxen

Product NDC
33261-081
11-digit product format
332610081
Labeler code
33261
Product ID
33261-081_4ac8c61d-66f2-49f0-959f-7f2a92137a61
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA075927
Marketing category
ANDA
Marketing start
2010-02-18
Marketing end
0000-00-00
Substance
NAPROXEN
Active strength
500 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
33261-081-022020-01-31C16284748780-19d75b9d0-49ba-f424-e053-dadaa90a57ceNaproxen Tablets, USP
33261-081-152020-01-31C16284748780-19d75b9d0-49ba-f424-e053-dadaa90a57ceNaproxen Tablets, USP
33261-081-202020-01-31C16284748780-19d75b9d0-49ba-f424-e053-dadaa90a57ceNaproxen Tablets, USP
33261-081-242020-01-31C16284748780-19d75b9d0-49ba-f424-e053-dadaa90a57ceNaproxen Tablets, USP
33261-081-302020-01-31C16284748780-19d75b9d0-49ba-f424-e053-dadaa90a57ceNaproxen Tablets, USP
33261-081-602020-01-31C16284748780-19d75b9d0-49ba-f424-e053-dadaa90a57ceNaproxen Tablets, USP
33261-081-902020-01-31C16284748780-19d75b9d0-49ba-f424-e053-dadaa90a57ceNaproxen Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-081-02Naproxen120 in 1 BOTTLE, PLASTICTABLET1201
33261-081-15Naproxen15 in 1 BOTTLE, PLASTICTABLET151
33261-081-20Naproxen20 in 1 BOTTLE, PLASTICTABLET201
33261-081-24Naproxen24 in 1 BOTTLE, PLASTICTABLET241
33261-081-30Naproxen30 in 1 BOTTLE, PLASTICTABLET301
33261-081-60Naproxen60 in 1 BOTTLE, PLASTICTABLET601
33261-081-90Naproxen90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-081-02EA - Each33261-0810ffb4bbe-83ce-4b5a-9633-16d307fcdc3b12015-10-02
33261-081-15EA - Each33261-0813fbb9a75-429e-4274-8f08-9d62cfe3236f12015-10-02
33261-081-20EA - Each33261-08151f08a2b-7644-4151-a3ab-3defb556a65212015-10-02
33261-081-30EA - Each33261-0815fc4a4db-0ab7-438c-9d94-621378ab5cb112015-10-02
33261-081-60EA - Each33261-0819e1ec852-6427-4acf-8ba5-d0a275b5e91d12015-10-02
33261-081-90EA - Each33261-081f0024e45-dc48-4b27-9dce-5144c56344bb12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [AIDAREX PHARMACEUTICALS LLC]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [AIDAREX PHARMACEUTICALS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [AIDAREX PHARMACEUTICALS LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-081NAPROXEN TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 7 package rows20140128_f23569ab-d9ac-45e8-b8f3-8d0ba612fc2d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198013naproxen 250 MG Oral TabletPSNf23569ab-d9ac-45e8-b8f3-8d0ba612fc2d1
198014naproxen 500 MG Oral TabletPSNf23569ab-d9ac-45e8-b8f3-8d0ba612fc2d1
198013naproxen 250 MG Oral TabletSCDf23569ab-d9ac-45e8-b8f3-8d0ba612fc2d1
198014naproxen 500 MG Oral TabletSCDf23569ab-d9ac-45e8-b8f3-8d0ba612fc2d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-081-0233261008102120 in 1 BOTTLE, PLASTICHistorical
33261-081-153326100811515 in 1 BOTTLE, PLASTICHistorical
33261-081-203326100812020 in 1 BOTTLE, PLASTICHistorical
33261-081-243326100812424 in 1 BOTTLE, PLASTICHistorical
33261-081-303326100813030 in 1 BOTTLE, PLASTICHistorical
33261-081-603326100816060 in 1 BOTTLE, PLASTICHistorical
33261-081-903326100819090 in 1 BOTTLE, PLASTICHistorical