FDA.reportPublic FDA data

Nabumetone

Product NDC
68151-0574
11-digit product format
681510574
Labeler code
68151
Product ID
68151-0574_28a6c43a-c01b-4be5-b385-cb8a76da1fa2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nabumetone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA091083
Marketing category
ANDA
Marketing start
2011-06-13
Marketing end
0000-00-00
Substance
NABUMETONE
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
9d4d18c4-d38e-37e1-df1c-ee38762bf8a5Product name420251024

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-0574-02020-01-31C16284748780-19d75b9d1-0fbd-f424-e053-dadaa90a57ceNabumetone Tablets USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-0574-0Nabumetone1 in 1 PACKAGETABLET, FILM COATED14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NABUMETONEACTIVE INGREDIENTLW0TIW155ZNABUMETONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
NABUMETONEACTIVE MOIETYLW0TIW155ZNABUMETONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONABUMETONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NABUMETONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ENABUMETONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NABUMETONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNABUMETONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2NABUMETONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNABUMETONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
TALCINACTIVE INGREDIENT7SEV7J4R1UNABUMETONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNABUMETONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
TRIACETININACTIVE INGREDIENTXHX3C3X673NABUMETONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-0574NABUMETONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]4Legacy NDC, 1 package rows20170706_ad87d83f-f10c-4804-aa27-6d9ecabc12d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311892nabumetone 500 MG Oral TabletPSNad87d83f-f10c-4804-aa27-6d9ecabc12d64
311892nabumetone 500 MG Oral TabletSCDad87d83f-f10c-4804-aa27-6d9ecabc12d64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-0574-0681510574001 in 1 PACKAGEHistorical