NABUMETONE

Product NDC
61919-159
11-digit product format
619190159
Labeler code
61919
Product ID
61919-159_9ca996d4-3b69-05db-e053-2995a90a9b81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NABUMETONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA075189
Marketing category
ANDA
Marketing start
2016-03-03
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
2021-12-31
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
61919-159-902023-01-30C16284748780-1d6a99b39-a086-a426-e053-dadaa90af4c2NABUMETONE 500mg
61919-159-902022-01-28C16284748780-1d6a99b39-a086-a426-e053-dadaa90af4c2NABUMETONE 500mg
61919-159-302020-01-31C16284748780-19d75b9cf-f560-f424-e053-dadaa90a57ceNABUMETONE
61919-159-602020-01-31C16284748780-19d75b9cf-f560-f424-e053-dadaa90a57ceNABUMETONE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-159-90NABUMETONE90 in 1 BOTTLETABLET, FILM COATED903
61919-159-30NABUMETONE30 in 1 BOTTLETABLET, FILM COATED302
61919-159-60NABUMETONE60 in 1 BOTTLETABLET, FILM COATED602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-159-60EA - Each61919-15937591a8f-f4fc-498f-94cc-ab3983bf9ac812014-05-02
61919-159-90EA - Each61919-15969c3a1b0-de69-4792-8448-c51d1c374e0212018-03-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NABUMETONEACTIVE INGREDIENTLW0TIW155ZNABUMETONE TABLET, FILM COATED [DIRECT RX]2
NABUMETONEACTIVE MOIETYLW0TIW155ZNABUMETONE TABLET, FILM COATED [DIRECT RX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNABUMETONE TABLET, FILM COATED [DIRECT RX]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NABUMETONE TABLET, FILM COATED [DIRECT RX]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNABUMETONE TABLET, FILM COATED [DIRECT RX]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NABUMETONE TABLET, FILM COATED [DIRECT RX]2
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82NABUMETONE TABLET, FILM COATED [DIRECT RX]2
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4NABUMETONE TABLET, FILM COATED [DIRECT RX]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQNABUMETONE TABLET, FILM COATED [DIRECT RX]2
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WENABUMETONE TABLET, FILM COATED [DIRECT RX]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NABUMETONE TABLET, FILM COATED [DIRECT RX]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNABUMETONE TABLET, FILM COATED [DIRECT RX]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2NABUMETONE TABLET, FILM COATED [DIRECT RX]2
TALCINACTIVE INGREDIENT7SEV7J4R1UNABUMETONE TABLET, FILM COATED [DIRECT RX]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNABUMETONE TABLET, FILM COATED [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-159NABUMETONE TABLET, FILM COATED [DIRECT RX]3Legacy NDC, 1 package rows20200131_2d8f206e-0853-43ca-e054-00144ff8d46c.zip
61919-159NABUMETONE TABLET, FILM COATED [DIRECT RX]2Legacy NDC, 2 package rows20150829_3cbe54ab-137b-4a1d-8490-d9e826cccbfc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311892nabumetone 500 MG Oral TabletPSN2d8f206e-0853-43ca-e054-00144ff8d46c3
311892nabumetone 500 MG Oral TabletSCD2d8f206e-0853-43ca-e054-00144ff8d46c3
311892nabumetone 500 MG Oral TabletPSN3cbe54ab-137b-4a1d-8490-d9e826cccbfc2
311893nabumetone 750 MG Oral TabletPSN3cbe54ab-137b-4a1d-8490-d9e826cccbfc2
311892nabumetone 500 MG Oral TabletSCD3cbe54ab-137b-4a1d-8490-d9e826cccbfc2
311893nabumetone 750 MG Oral TabletSCD3cbe54ab-137b-4a1d-8490-d9e826cccbfc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-159-306191901593030 in 1 BOTTLEHistorical
61919-159-606191901596060 in 1 BOTTLEHistorical
61919-159-906191901599090 TABLET, FILM COATED in 1 BOTTLE (61919-159-90) 2016-03-030000-00-00NoNoCurrent