Naproxen

Product NDC
33261-080
11-digit product format
332610080
Labeler code
33261
Product ID
33261-080_7e3dcdf1-4ba5-458d-b4e1-20ab4e9dda2b
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
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-080-402020-01-31C16284748780-19d75b9d0-1420-f424-e053-dadaa90a57ceNaproxen Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-080-40Naproxen40 in 1 BOTTLETABLET401

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-080-40EA - Each33261-08022006a37-a0cd-4683-84c4-42a5c9793a4812013-02-13

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
33261-080NAPROXEN TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20120901_2a6133ff-285d-4026-bbd6-e99f84b63820.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198012naproxen 375 MG Oral TabletPSN2a6133ff-285d-4026-bbd6-e99f84b638201
198012naproxen 375 MG Oral TabletSCD2a6133ff-285d-4026-bbd6-e99f84b638201

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-080-403326100804040 in 1 BOTTLEHistorical