FDA.reportPublic FDA data

Nabumetone

Product NDC
45865-464
11-digit product format
458650464
Labeler code
45865
Product ID
45865-464_9ab28852-3dee-308b-e053-2a95a90ae192
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nabumetone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA078671
Marketing category
ANDA
Marketing start
2008-03-01
Marketing end
0000-00-00
Substance
NABUMETONE
Active strength
500 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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9d4d18c4-d38e-37e1-df1c-ee38762bf8a5Product name420251024

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45865-464-602025-01-30C16284748780-12cef2736-6a52-d83d-e063-dadaa90ab31fNabumetone Tablets USP
45865-464-902025-01-30C16284748780-12cef2736-6a52-d83d-e063-dadaa90ab31fNabumetone Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-464-60Nabumetone60 in 1 BOTTLETABLET, FILM COATED602
45865-464-90Nabumetone90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NABUMETONEACTIVE INGREDIENTLW0TIW155ZNABUMETONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
NABUMETONEACTIVE MOIETYLW0TIW155ZNABUMETONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNABUMETONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONABUMETONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NABUMETONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
POLYETHYLENE GLYCOL 200INACTIVE INGREDIENTR95B8J264JNABUMETONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HNABUMETONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NABUMETONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNABUMETONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2NABUMETONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNABUMETONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-464NABUMETONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]2Legacy NDC, 2 package rows20191228_1dd75aec-e84e-1eb3-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311892nabumetone 500 MG Oral TabletPSN1dd75aec-e84e-1eb3-e054-00144ff8d46c2
311892nabumetone 500 MG Oral TabletSCD1dd75aec-e84e-1eb3-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-464-604586504646060 TABLET, FILM COATED in 1 BOTTLE (45865-464-60) 2015-08-260000-00-00NoNoCurrent
45865-464-904586504649090 TABLET, FILM COATED in 1 BOTTLE (45865-464-90) 2015-08-260000-00-00NoNoCurrent