FDA.reportPublic FDA data

Nabumetone

Product NDC
71335-1559
11-digit product format
713351559
Labeler code
71335
Product ID
71335-1559_0f7ff985-21f9-421c-b8bd-bff24abe998e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nabumetone
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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
71335-1559-0Nabumetone7 in 1 BOTTLETABLET7103
71335-1559-1Nabumetone60 in 1 BOTTLETABLET60103
71335-1559-2Nabumetone90 in 1 BOTTLETABLET90103
71335-1559-3Nabumetone30 in 1 BOTTLETABLET30103
71335-1559-4Nabumetone20 in 1 BOTTLETABLET20103
71335-1559-5Nabumetone42 in 1 BOTTLETABLET42103
71335-1559-6Nabumetone100 in 1 BOTTLETABLET100103
71335-1559-7Nabumetone14 in 1 BOTTLETABLET14103
71335-1559-8Nabumetone6 in 1 BOTTLETABLET6103
71335-1559-9Nabumetone9 in 1 BOTTLETABLET9103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1559-1EA - Each71335-1559017d42f6-81aa-436a-9436-0fee7f6f983012021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1559NABUMETONE TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 10 package rows20250402_b2a41c0b-e2ad-4e14-a2f7-2049c12c35da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311893nabumetone 750 MG Oral TabletPSNb2a41c0b-e2ad-4e14-a2f7-2049c12c35da103
311893nabumetone 750 MG Oral TabletSCDb2a41c0b-e2ad-4e14-a2f7-2049c12c35da103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1559-0713351559007 TABLET in 1 BOTTLE (71335-1559-0) 7 tablet2022-02-100000-00-00NoNoCurrent
71335-1559-17133515590160 TABLET in 1 BOTTLE (71335-1559-1) 60 tablet2022-02-100000-00-00NoNoCurrent
71335-1559-27133515590290 TABLET in 1 BOTTLE (71335-1559-2) 90 tablet2022-02-100000-00-00NoNoCurrent
71335-1559-37133515590330 TABLET in 1 BOTTLE (71335-1559-3) 30 tablet2022-02-100000-00-00NoNoCurrent
71335-1559-47133515590420 TABLET in 1 BOTTLE (71335-1559-4) 20 tablet2022-02-100000-00-00NoNoCurrent
71335-1559-57133515590542 TABLET in 1 BOTTLE (71335-1559-5) 42 tablet2022-02-100000-00-00NoNoCurrent
71335-1559-671335155906100 TABLET in 1 BOTTLE (71335-1559-6) 100 tablet2022-02-100000-00-00NoNoCurrent
71335-1559-77133515590714 TABLET in 1 BOTTLE (71335-1559-7) 14 tablet2022-02-100000-00-00NoNoCurrent
71335-1559-8713351559086 TABLET in 1 BOTTLE (71335-1559-8) 6 tablet2022-02-100000-00-00NoNoCurrent
71335-1559-9713351559099 TABLET in 1 BOTTLE (71335-1559-9) 9 tablet2022-02-100000-00-00NoNoCurrent