Nabumetone

Product NDC
68180-142
11-digit product format
681800142
Labeler code
68180
Product ID
68180-142_54834b73-96d1-4f73-953d-a3407be454d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nabumetone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA090445
Marketing category
ANDA
Marketing start
2011-01-12
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-142-01Nabumetone100 in 1 BOTTLETABLET, FILM COATED1004
68180-142-03Nabumetone1000 in 1 BOTTLETABLET, FILM COATED10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-142-01EA - Each68180-1426548a44a-208d-4653-a318-00a9e35aa03a12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NABUMETONEACTIVE INGREDIENTLW0TIW155ZNABUMETONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]2
NABUMETONEACTIVE MOIETYLW0TIW155ZNABUMETONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNABUMETONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]2
HYPROMELLOSE 2208 (3 MPA.S)INACTIVE INGREDIENT9H4L916OBUNABUMETONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]2
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82NABUMETONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NABUMETONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQNABUMETONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NABUMETONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNABUMETONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2NABUMETONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNABUMETONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-142NABUMETONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 2 package rows20231104_cf96d189-5417-4181-a5fb-169b269560a2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311892nabumetone 500 MG Oral TabletPSNcf96d189-5417-4181-a5fb-169b269560a24
311893nabumetone 750 MG Oral TabletPSNcf96d189-5417-4181-a5fb-169b269560a24
311892nabumetone 500 MG Oral TabletSCDcf96d189-5417-4181-a5fb-169b269560a24
311893nabumetone 750 MG Oral TabletSCDcf96d189-5417-4181-a5fb-169b269560a24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68180-142-0168180014201100 TABLET, FILM COATED in 1 BOTTLE (68180-142-01) 2011-01-120000-00-00NoNoCurrent
68180-142-03681800142031000 TABLET, FILM COATED in 1 BOTTLE (68180-142-03) 2011-01-120000-00-00NoNoCurrent