Nabumetone

Product NDC
0591-3671
11-digit product format
005913671
Labeler code
0591
Product ID
0591-3671_50a45f4a-452a-43d5-8f93-38b1023dec1e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nabumetone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA091083
Marketing category
ANDA
Marketing start
2011-06-13
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
0591-3671-01Nabumetone100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10023
0591-3671-05Nabumetone500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-3671-01EA - Each0591-3671bbc32216-e36f-48e4-8b17-c8e33ba2475b12012-07-24
0591-3671-05EA - Each0591-3671f389743c-9738-424d-b524-3e0bcc4c7e3512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NABUMETONEACTIVE INGREDIENTLW0TIW155ZNABUMETONE TABLET, FILM COATED [WATSON LABORATORIES, INC.]6
NABUMETONEACTIVE MOIETYLW0TIW155ZNABUMETONE TABLET, FILM COATED [WATSON LABORATORIES, INC.]6
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NABUMETONE TABLET, FILM COATED [WATSON LABORATORIES, INC.]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NABUMETONE TABLET, FILM COATED [WATSON LABORATORIES, INC.]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONABUMETONE TABLET, FILM COATED [WATSON LABORATORIES, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NABUMETONE TABLET, FILM COATED [WATSON LABORATORIES, INC.]6
POVIDONEINACTIVE INGREDIENTFZ989GH94ENABUMETONE TABLET, FILM COATED [WATSON LABORATORIES, INC.]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNABUMETONE TABLET, FILM COATED [WATSON LABORATORIES, INC.]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2NABUMETONE TABLET, FILM COATED [WATSON LABORATORIES, INC.]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNABUMETONE TABLET, FILM COATED [WATSON LABORATORIES, INC.]6
TALCINACTIVE INGREDIENT7SEV7J4R1UNABUMETONE TABLET, FILM COATED [WATSON LABORATORIES, INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNABUMETONE TABLET, FILM COATED [WATSON LABORATORIES, INC.]6
TRIACETININACTIVE INGREDIENTXHX3C3X673NABUMETONE TABLET, FILM COATED [WATSON LABORATORIES, INC.]6
NABUMETONEACTIVE INGREDIENTLW0TIW155ZNABUMETONE TABLET, FILM COATED [PROFICIENT RX LP]1
NABUMETONEACTIVE MOIETYLW0TIW155ZNABUMETONE TABLET, FILM COATED [PROFICIENT RX LP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NABUMETONE TABLET, FILM COATED [PROFICIENT RX LP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONABUMETONE TABLET, FILM COATED [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NABUMETONE TABLET, FILM COATED [PROFICIENT RX LP]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ENABUMETONE TABLET, FILM COATED [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NABUMETONE TABLET, FILM COATED [PROFICIENT RX LP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNABUMETONE TABLET, FILM COATED [PROFICIENT RX LP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2NABUMETONE TABLET, FILM COATED [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNABUMETONE TABLET, FILM COATED [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNABUMETONE TABLET, FILM COATED [PROFICIENT RX LP]1
TRIACETININACTIVE INGREDIENTXHX3C3X673NABUMETONE TABLET, FILM COATED [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-3671NABUMETONE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]22Current NDC, Legacy NDC, 2 package rows20250501_53656d70-6572-4669-6465-6c6973555341.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311893nabumetone 750 MG Oral TabletPSN0186328f-3eb7-4407-bf9e-8007d08ebe7b103
311893nabumetone 750 MG Oral TabletSCD0186328f-3eb7-4407-bf9e-8007d08ebe7b103
311892nabumetone 500 MG Oral TabletPSN53656d70-6572-4669-6465-6c697355534123
311893nabumetone 750 MG Oral TabletPSN53656d70-6572-4669-6465-6c697355534123
311892nabumetone 500 MG Oral TabletSCD53656d70-6572-4669-6465-6c697355534123
311893nabumetone 750 MG Oral TabletSCD53656d70-6572-4669-6465-6c697355534123
311893nabumetone 750 MG Oral TabletPSN466f4261-4b7c-4502-9f00-8d0c7e46ac8914
311893nabumetone 750 MG Oral TabletSCD466f4261-4b7c-4502-9f00-8d0c7e46ac8914
311893nabumetone 750 MG Oral TabletPSN079a8a9e-6d71-414a-83f3-ef68e323c1fd3
311893nabumetone 750 MG Oral TabletSCD079a8a9e-6d71-414a-83f3-ef68e323c1fd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-3671-0100591367101100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-3671-01) 2011-06-130000-00-00NoNoCurrent
0591-3671-0500591367105500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-3671-05) 2011-06-130000-00-00NoNoCurrent
0591-3671-10005913671101000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-3671-10) 2011-06-130000-00-00NoNoCurrent