FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
33261-085
11-digit product format
332610085
Labeler code
33261
Product ID
33261-085_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
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
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
33261-085-002020-01-31C16284748780-19d75b9d1-24db-f424-e053-dadaa90a57ceNaproxen Sodium Tablets, USP 275 mg and 550 mg
33261-085-022020-01-31C16284748780-19d75b9d1-24db-f424-e053-dadaa90a57ceNaproxen Sodium Tablets, USP 275 mg and 550 mg
33261-085-142020-01-31C16284748780-19d75b9d1-24db-f424-e053-dadaa90a57ceNaproxen Sodium Tablets, USP 275 mg and 550 mg
33261-085-202020-01-31C16284748780-19d75b9d1-24db-f424-e053-dadaa90a57ceNaproxen Sodium Tablets, USP 275 mg and 550 mg
33261-085-212020-01-31C16284748780-19d75b9d1-24db-f424-e053-dadaa90a57ceNaproxen Sodium Tablets, USP 275 mg and 550 mg
33261-085-302020-01-31C16284748780-19d75b9d1-24db-f424-e053-dadaa90a57ceNaproxen Sodium Tablets, USP 275 mg and 550 mg
33261-085-602020-01-31C16284748780-19d75b9d1-24db-f424-e053-dadaa90a57ceNaproxen Sodium Tablets, USP 275 mg and 550 mg
33261-085-842020-01-31C16284748780-19d75b9d1-24db-f424-e053-dadaa90a57ceNaproxen Sodium Tablets, USP 275 mg and 550 mg
33261-085-902020-01-31C16284748780-19d75b9d1-24db-f424-e053-dadaa90a57ceNaproxen Sodium Tablets, USP 275 mg and 550 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-085-00Naproxen Sodium100 in 1 BOTTLE, PLASTICTABLET1001
33261-085-02Naproxen Sodium120 in 1 BOTTLE, PLASTICTABLET1201
33261-085-14Naproxen Sodium14 in 1 BOTTLE, PLASTICTABLET141
33261-085-20Naproxen Sodium20 in 1 BOTTLE, PLASTICTABLET201
33261-085-21Naproxen Sodium21 in 1 BOTTLE, PLASTICTABLET211
33261-085-30Naproxen Sodium30 in 1 BOTTLE, PLASTICTABLET301
33261-085-60Naproxen Sodium60 in 1 BOTTLE, PLASTICTABLET601
33261-085-84Naproxen Sodium84 in 1 BOTTLE, PLASTICTABLET841
33261-085-90Naproxen Sodium90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-085-00EA - Each33261-0855a093d2c-8b45-408b-86dd-339a0c6ce27412015-10-02
33261-085-02EA - Each33261-0855b64841a-4fcb-423c-9fe2-d4f3eb4ba2e012014-02-04
33261-085-14EA - Each33261-085600894a0-cbdd-4620-a7f7-e7a0f5f929cc12014-02-04
33261-085-20EA - Each33261-0858cc6287c-f602-4631-9434-5451e57afcc812014-02-04
33261-085-21EA - Each33261-08510544f3d-9f68-47b2-ac3c-e9ca614c983f12014-02-04
33261-085-30EA - Each33261-08573b66fad-c50b-4e85-a38c-0802510bbb0712015-10-02
33261-085-60EA - Each33261-08540298a87-ed12-4718-bf17-f43e663bbdac12014-02-04
33261-085-84EA - Each33261-0852148411a-16e7-4c72-8082-6711c098764612015-10-02
33261-085-90EA - Each33261-0859c54c69d-298e-4db9-9653-82ac890d04ec12014-02-04

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
33261-085NAPROXEN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 9 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
33261-085-0033261008500100 in 1 BOTTLE, PLASTICHistorical
33261-085-0233261008502120 in 1 BOTTLE, PLASTICHistorical
33261-085-143326100851414 in 1 BOTTLE, PLASTICHistorical
33261-085-203326100852020 in 1 BOTTLE, PLASTICHistorical
33261-085-213326100852121 in 1 BOTTLE, PLASTICHistorical
33261-085-303326100853030 in 1 BOTTLE, PLASTICHistorical
33261-085-603326100856060 in 1 BOTTLE, PLASTICHistorical
33261-085-843326100858484 in 1 BOTTLE, PLASTICHistorical
33261-085-903326100859090 in 1 BOTTLE, PLASTICHistorical