Nabumetone

Product NDC
76282-258
11-digit product format
762820258
Labeler code
76282
Product ID
76282-258_11f0008a-dff5-4fd3-8f48-76d033ea87f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nabumetone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Exelan Pharmaceuticals Inc.
Application
ANDA078671
Marketing category
ANDA
Marketing start
2015-04-14
Substance
NABUMETONE
Active strength
750 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nabumetone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NABUMETONE750 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLW0TIW155Z
Rxcui311892, 311893

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76282-258-01Nabumetone100 in 1 BOTTLETABLET, FILM COATED10011
76282-258-05Nabumetone500 in 1 BOTTLETABLET, FILM COATED50011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-258-01EA - Each76282-25869f755ff-427d-44e6-80eb-ee5a69d4a16412014-05-02
76282-258-05EA - Each76282-2581209d147-8704-42c2-8b5f-7222f405574612014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NABUMETONEACTIVE INGREDIENTLW0TIW155ZNABUMETONE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]3
NABUMETONEACTIVE MOIETYLW0TIW155ZNABUMETONE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNABUMETONE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NABUMETONE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONABUMETONE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NABUMETONE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNABUMETONE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2NABUMETONE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-258NABUMETONE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 2 package rows20250410_16e76e29-9315-40c0-b1d6-8d91961063cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311892nabumetone 500 MG Oral TabletPSN16e76e29-9315-40c0-b1d6-8d91961063cf11
311893nabumetone 750 MG Oral TabletPSN16e76e29-9315-40c0-b1d6-8d91961063cf11
311892nabumetone 500 MG Oral TabletSCD16e76e29-9315-40c0-b1d6-8d91961063cf11
311893nabumetone 750 MG Oral TabletSCD16e76e29-9315-40c0-b1d6-8d91961063cf11
311892nabumetone 500 MG Oral TabletPSNa79322ab-2af6-4d43-8548-85bfa3ea5e2c1
311893nabumetone 750 MG Oral TabletPSNa79322ab-2af6-4d43-8548-85bfa3ea5e2c1
311892nabumetone 500 MG Oral TabletSCDa79322ab-2af6-4d43-8548-85bfa3ea5e2c1
311893nabumetone 750 MG Oral TabletSCDa79322ab-2af6-4d43-8548-85bfa3ea5e2c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76282-258-0176282025801100 TABLET, FILM COATED in 1 BOTTLE (76282-258-01) 2015-04-140000-00-00NoNoCurrent
76282-258-0576282025805500 TABLET, FILM COATED in 1 BOTTLE (76282-258-05) 2015-04-140000-00-00NoNoCurrent