FDA.reportPublic FDA data

NABUMETONE

Product NDC
72189-184
11-digit product format
721890184
Labeler code
72189
Product ID
72189-184_2be95f19-e557-ab96-e063-6394a90a6947
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NABUMETONE
Dosage form
TABLET
Route
ORAL
Labeler
direct rx
Application
ANDA078420
Marketing category
ANDA
Marketing start
2021-05-11
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, 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
72189-184-14NABUMETONE14 in 1 BOTTLETABLET1411
72189-184-30NABUMETONE30 in 1 BOTTLETABLET3011
72189-184-60NABUMETONE60 in 1 BOTTLETABLET6011
72189-184-90NABUMETONE90 in 1 BOTTLETABLET9011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-184NABUMETONE TABLET [DIRECT RX]11Current NDC, Legacy NDC, 4 package rows20250119_a8600b12-f180-0b27-e053-2995a90acbd9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311892nabumetone 500 MG Oral TabletPSNa8600b12-f180-0b27-e053-2995a90acbd911
311893nabumetone 750 MG Oral TabletPSNa8600b12-f180-0b27-e053-2995a90acbd911
311892nabumetone 500 MG Oral TabletSCDa8600b12-f180-0b27-e053-2995a90acbd911
311893nabumetone 750 MG Oral TabletSCDa8600b12-f180-0b27-e053-2995a90acbd911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-184-147218901841414 TABLET in 1 BOTTLE (72189-184-14) 14 tablet2021-05-110000-00-00NoNoCurrent
72189-184-307218901843030 TABLET in 1 BOTTLE (72189-184-30) 30 tablet2021-05-110000-00-00NoNoCurrent
72189-184-607218901846060 TABLET in 1 BOTTLE (72189-184-60) 60 tablet2021-05-110000-00-00NoNoCurrent
72189-184-907218901849090 TABLET in 1 BOTTLE (72189-184-90) 90 tablet2021-05-110000-00-00NoNoCurrent