FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
33261-084
11-digit product format
332610084
Labeler code
33261
Product ID
33261-084_f67ff8f9-fff1-4cd4-abc6-819b577837dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA078432
Marketing category
ANDA
Marketing start
2007-04-26
Marketing end
0000-00-00
Substance
NAPROXEN SODIUM
Active strength
275 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
33261-084-602020-01-31C16284748780-19d75b9d1-24db-f424-e053-dadaa90a57ceNaproxen Sodium Tablets, USP 275 mg and 550 mg
33261-084-902020-01-31C16284748780-19d75b9d1-24db-f424-e053-dadaa90a57ceNaproxen Sodium Tablets, USP 275 mg and 550 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-084-60Naproxen Sodium60 in 1 BOTTLE, PLASTICTABLET601
33261-084-90Naproxen Sodium90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNAPROXEN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990NAPROXEN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ENAPROXEN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UNAPROXEN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAPROXEN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-084NAPROXEN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 2 package rows20140128_30cc16cd-720d-4baa-8941-bfdc28b62b04.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849398naproxen sodium 275 MG Oral TabletPSN30cc16cd-720d-4baa-8941-bfdc28b62b041
849431naproxen sodium 550 MG Oral TabletPSN30cc16cd-720d-4baa-8941-bfdc28b62b041
849398naproxen sodium 275 MG Oral TabletSCD30cc16cd-720d-4baa-8941-bfdc28b62b041
849431naproxen sodium 550 MG Oral TabletSCD30cc16cd-720d-4baa-8941-bfdc28b62b041
849398naproxen sodium 275 MG (as naproxen 250 MG) Oral TabletSY30cc16cd-720d-4baa-8941-bfdc28b62b041
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY30cc16cd-720d-4baa-8941-bfdc28b62b041

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-084-603326100846060 in 1 BOTTLE, PLASTICHistorical
33261-084-903326100849090 in 1 BOTTLE, PLASTICHistorical