FDA.reportPublic FDA data

Nabumetone

Product NDC
71335-1272
11-digit product format
713351272
Labeler code
71335
Product ID
71335-1272_36130e12-3b36-4096-aae8-bf3715dab6e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nabumetone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091083
Marketing category
ANDA
Marketing start
2011-06-13
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1272-02025-09-23C16284748780-11030e365-3edf-111a-e063-dadaa90a10e2Nabumetone Tablets, USP Rx only
71335-1272-12025-09-23C16284748780-11030e365-3edf-111a-e063-dadaa90a10e2Nabumetone Tablets, USP Rx only
71335-1272-22025-09-23C16284748780-11030e365-3edf-111a-e063-dadaa90a10e2Nabumetone Tablets, USP Rx only
71335-1272-32025-09-23C16284748780-11030e365-3edf-111a-e063-dadaa90a10e2Nabumetone Tablets, USP Rx only
71335-1272-42025-09-23C16284748780-11030e365-3edf-111a-e063-dadaa90a10e2Nabumetone Tablets, USP Rx only
71335-1272-52025-09-23C16284748780-11030e365-3edf-111a-e063-dadaa90a10e2Nabumetone Tablets, USP Rx only
71335-1272-62025-09-23C16284748780-11030e365-3edf-111a-e063-dadaa90a10e2Nabumetone Tablets, USP Rx only
71335-1272-72025-09-23C16284748780-11030e365-3edf-111a-e063-dadaa90a10e2Nabumetone Tablets, USP Rx only
71335-1272-82025-09-23C16284748780-11030e365-3edf-111a-e063-dadaa90a10e2Nabumetone Tablets, USP Rx only
71335-1272-92025-09-23C16284748780-11030e365-3edf-111a-e063-dadaa90a10e2Nabumetone Tablets, USP Rx only
71335-1272-02024-01-30C16284748780-11030e365-3edf-111a-e063-dadaa90a10e2Nabumetone Tablets, USP Rx only
71335-1272-12024-01-30C16284748780-11030e365-3edf-111a-e063-dadaa90a10e2Nabumetone Tablets, USP Rx only
71335-1272-22024-01-30C16284748780-11030e365-3edf-111a-e063-dadaa90a10e2Nabumetone Tablets, USP Rx only
71335-1272-32024-01-30C16284748780-11030e365-3edf-111a-e063-dadaa90a10e2Nabumetone Tablets, USP Rx only
71335-1272-42024-01-30C16284748780-11030e365-3edf-111a-e063-dadaa90a10e2Nabumetone Tablets, USP Rx only
71335-1272-52024-01-30C16284748780-11030e365-3edf-111a-e063-dadaa90a10e2Nabumetone Tablets, USP Rx only
71335-1272-62024-01-30C16284748780-11030e365-3edf-111a-e063-dadaa90a10e2Nabumetone Tablets, USP Rx only
71335-1272-72024-01-30C16284748780-11030e365-3edf-111a-e063-dadaa90a10e2Nabumetone Tablets, USP Rx only
71335-1272-82024-01-30C16284748780-11030e365-3edf-111a-e063-dadaa90a10e2Nabumetone Tablets, USP Rx only
71335-1272-92024-01-30C16284748780-11030e365-3edf-111a-e063-dadaa90a10e2Nabumetone Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1272-0Nabumetone7 in 1 BOTTLETABLET, FILM COATED7103
71335-1272-1Nabumetone60 in 1 BOTTLETABLET, FILM COATED60103
71335-1272-2Nabumetone90 in 1 BOTTLETABLET, FILM COATED90103
71335-1272-3Nabumetone30 in 1 BOTTLETABLET, FILM COATED30103
71335-1272-4Nabumetone20 in 1 BOTTLETABLET, FILM COATED20103
71335-1272-5Nabumetone42 in 1 BOTTLETABLET, FILM COATED42103
71335-1272-6Nabumetone100 in 1 BOTTLETABLET, FILM COATED100103
71335-1272-7Nabumetone14 in 1 BOTTLETABLET, FILM COATED14103
71335-1272-8Nabumetone6 in 1 BOTTLETABLET, FILM COATED6103
71335-1272-9Nabumetone9 in 1 BOTTLETABLET, FILM COATED9103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1272-1EA - Each71335-12722eddb867-52fb-4166-af82-8a6fb926d4f012019-11-12
71335-1272-3EA - Each71335-12721d1672f4-fa02-4390-ab40-60e2bc72a23112019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1272NABUMETONE TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 10 package rows20220701_0186328f-3eb7-4407-bf9e-8007d08ebe7b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311893nabumetone 750 MG Oral TabletPSN0186328f-3eb7-4407-bf9e-8007d08ebe7b103
311893nabumetone 750 MG Oral TabletSCD0186328f-3eb7-4407-bf9e-8007d08ebe7b103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1272-0713351272007 TABLET, FILM COATED in 1 BOTTLE (71335-1272-0) 2022-06-290000-00-00NoNoCurrent
71335-1272-17133512720160 TABLET, FILM COATED in 1 BOTTLE (71335-1272-1) 2019-07-160000-00-00NoNoCurrent
71335-1272-27133512720290 TABLET, FILM COATED in 1 BOTTLE (71335-1272-2) 2022-06-290000-00-00NoNoCurrent
71335-1272-37133512720330 TABLET, FILM COATED in 1 BOTTLE (71335-1272-3) 2019-07-170000-00-00NoNoCurrent
71335-1272-47133512720420 TABLET, FILM COATED in 1 BOTTLE (71335-1272-4) 2022-06-290000-00-00NoNoCurrent
71335-1272-57133512720542 TABLET, FILM COATED in 1 BOTTLE (71335-1272-5) 2022-06-290000-00-00NoNoCurrent
71335-1272-671335127206100 TABLET, FILM COATED in 1 BOTTLE (71335-1272-6) 2022-06-290000-00-00NoNoCurrent
71335-1272-77133512720714 TABLET, FILM COATED in 1 BOTTLE (71335-1272-7) 2022-06-290000-00-00NoNoCurrent
71335-1272-8713351272086 TABLET, FILM COATED in 1 BOTTLE (71335-1272-8) 2022-06-290000-00-00NoNoCurrent
71335-1272-9713351272099 TABLET, FILM COATED in 1 BOTTLE (71335-1272-9) 2022-06-290000-00-00NoNoCurrent