Nabumetone

Product NDC
50436-6046
11-digit product format
504366046
Labeler code
50436
Product ID
50436-6046_0daa6ea0-5367-4ad4-bfff-ddf3afc5830c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nabumetone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
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
50436-6046-12021-01-29C16284748780-1ba0f9c33-2c97-a910-e053-dadaa90a0b85Nabumetone Tablets USP
50436-6046-22021-01-29C16284748780-1ba0f9c33-2c97-a910-e053-dadaa90a0b85Nabumetone Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-6046-1Nabumetone30 in 1 BOTTLETABLET, FILM COATED305
50436-6046-2Nabumetone60 in 1 BOTTLETABLET, FILM COATED605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-6046-1EA - Each50436-6046dce818ea-08e7-4499-afee-a201573e2ee712015-10-02
50436-6046-2EA - Each50436-6046f85b4a15-e998-4325-a968-9c421338c18112014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NABUMETONEACTIVE INGREDIENTLW0TIW155ZNABUMETONE TABLET, FILM COATED [UNIT DOSE SERVICES]3
NABUMETONEACTIVE MOIETYLW0TIW155ZNABUMETONE TABLET, FILM COATED [UNIT DOSE SERVICES]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNABUMETONE TABLET, FILM COATED [UNIT DOSE SERVICES]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONABUMETONE TABLET, FILM COATED [UNIT DOSE SERVICES]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NABUMETONE TABLET, FILM COATED [UNIT DOSE SERVICES]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANABUMETONE TABLET, FILM COATED [UNIT DOSE SERVICES]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HNABUMETONE TABLET, FILM COATED [UNIT DOSE SERVICES]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NABUMETONE TABLET, FILM COATED [UNIT DOSE SERVICES]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNABUMETONE TABLET, FILM COATED [UNIT DOSE SERVICES]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNABUMETONE TABLET, FILM COATED [UNIT DOSE SERVICES]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-6046NABUMETONE TABLET, FILM COATED [UNIT DOSE SERVICES]5Legacy NDC, 2 package rows20170702_9df9212a-cf34-42b4-bd84-796b9e981eb0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311892nabumetone 500 MG Oral TabletPSN9df9212a-cf34-42b4-bd84-796b9e981eb05
311892nabumetone 500 MG Oral TabletSCD9df9212a-cf34-42b4-bd84-796b9e981eb05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-6046-15043660460130 in 1 BOTTLEHistorical
50436-6046-25043660460260 in 1 BOTTLEHistorical