FDA.reportPublic FDA data

Nabumetone

Product NDC
80425-0104
11-digit product format
804250104
Labeler code
80425
Product ID
80425-0104_2a99aae5-c902-7940-e063-6294a90a4146
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nabumetone
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA078420
Marketing category
ANDA
Marketing start
2019-06-26
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
Rxcui311893

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
80425-0104-1Nabumetone30 in 1 BOTTLETABLET306
80425-0104-2Nabumetone60 in 1 BOTTLETABLET606
80425-0104-3Nabumetone90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0104-1EA - Each80425-01048347823d-cf0f-4cb3-a810-a841e122579b12023-06-06
80425-0104-2EA - Each80425-0104eb7213a9-c436-4260-9a66-76a9d1e34c2e12023-06-06
80425-0104-3EA - Each80425-0104ae4759d9-08ef-477f-86f2-95f67785c7fc12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0104NABUMETONE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]6Current NDC, Legacy NDC, 3 package rows20250101_b43db4aa-6013-3942-e053-2a95a90a5189.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311893nabumetone 750 MG Oral TabletPSNb43db4aa-6013-3942-e053-2a95a90a51896
311893nabumetone 750 MG Oral TabletSCDb43db4aa-6013-3942-e053-2a95a90a51896

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0104-18042501040130 TABLET in 1 BOTTLE (80425-0104-1) 30 tablet2019-06-260000-00-00NoNoCurrent
80425-0104-28042501040260 TABLET in 1 BOTTLE (80425-0104-2) 60 tablet2023-04-07NoNoHistorical
80425-0104-38042501040390 TABLET in 1 BOTTLE (80425-0104-3) 90 tablet2023-04-07NoNoHistorical