Nabumetone

Product NDC
80425-0054
11-digit product format
804250054
Labeler code
80425
Product ID
80425-0054_2a98f01a-8d9d-0770-e063-6294a90a7bab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nabumetone
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA078420
Marketing category
ANDA
Marketing start
2019-06-26
Substance
NABUMETONE
Active strength
500 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
NABUMETONE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLW0TIW155Z
Rxcui311892

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
80425-0054-1Nabumetone60 in 1 BOTTLETABLET606
80425-0054-2Nabumetone90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0054-1EA - Each80425-00545d8d5bfa-9e71-471d-b8a5-4ece884b351012023-06-06
80425-0054-2EA - Each80425-00542b04fc85-aa80-421e-b6c5-b5834462941112023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0054NABUMETONE TABLET [ADVANCED RX OF TENNESSEE, LLC]6Current NDC, Legacy NDC, 2 package rows20250101_af9994ac-6687-2df2-e053-2995a90a959a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311892nabumetone 500 MG Oral TabletPSNaf9994ac-6687-2df2-e053-2995a90a959a6
311892nabumetone 500 MG Oral TabletSCDaf9994ac-6687-2df2-e053-2995a90a959a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0054-18042500540160 TABLET in 1 BOTTLE (80425-0054-1) 60 tablet2019-06-260000-00-00NoNoCurrent
80425-0054-28042500540290 TABLET in 1 BOTTLE (80425-0054-2) 90 tablet2019-06-260000-00-00NoNoCurrent