FDA.reportPublic FDA data

Nabumetone

Product NDC
71205-530
11-digit product format
712050530
Labeler code
71205
Product ID
71205-530_143af59b-1513-46bd-8f77-63c04bdbd07c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nabumetone
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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
71205-530-30Nabumetone30 in 1 BOTTLETABLET302
71205-530-60Nabumetone60 in 1 BOTTLETABLET602
71205-530-90Nabumetone90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-530-30EA - Each71205-530b06e9369-36b0-4b0c-af13-80c4c4ff9d0612021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-530NABUMETONE TABLET [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20220421_f4392863-ed3f-4fbd-8260-49827609aa2e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311893nabumetone 750 MG Oral TabletPSNf4392863-ed3f-4fbd-8260-49827609aa2e2
311893nabumetone 750 MG Oral TabletSCDf4392863-ed3f-4fbd-8260-49827609aa2e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-530-307120505303030 TABLET in 1 BOTTLE (71205-530-30) 30 tablet2021-02-030000-00-00NoNoCurrent
71205-530-607120505306060 TABLET in 1 BOTTLE (71205-530-60) 60 tablet2021-02-030000-00-00NoNoCurrent
71205-530-907120505309090 TABLET in 1 BOTTLE (71205-530-90) 90 tablet2021-02-030000-00-00NoNoCurrent