FDA.reportPublic FDA data

Nabumetone

Product NDC
71335-1234
11-digit product format
713351234
Labeler code
71335
Product ID
71335-1234_8b05e389-e1cc-47d1-b24e-10f247ca7f14
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
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

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
71335-1234-12025-09-18C16284748780-11030e365-5b4a-111a-e063-dadaa90a10e2Nabumetone Tablets, USP Rx only
71335-1234-22025-09-18C16284748780-11030e365-5b4a-111a-e063-dadaa90a10e2Nabumetone Tablets, USP Rx only
71335-1234-32025-09-18C16284748780-11030e365-5b4a-111a-e063-dadaa90a10e2Nabumetone Tablets, USP Rx only
71335-1234-42025-09-18C16284748780-11030e365-5b4a-111a-e063-dadaa90a10e2Nabumetone Tablets, USP Rx only
71335-1234-52025-09-18C16284748780-11030e365-5b4a-111a-e063-dadaa90a10e2Nabumetone Tablets, USP Rx only
71335-1234-62025-09-18C16284748780-11030e365-5b4a-111a-e063-dadaa90a10e2Nabumetone Tablets, USP Rx only
71335-1234-72025-09-18C16284748780-11030e365-5b4a-111a-e063-dadaa90a10e2Nabumetone Tablets, USP Rx only
71335-1234-82025-09-18C16284748780-11030e365-5b4a-111a-e063-dadaa90a10e2Nabumetone Tablets, USP Rx only
71335-1234-92025-09-18C16284748780-11030e365-5b4a-111a-e063-dadaa90a10e2Nabumetone Tablets, USP Rx only
71335-1234-12024-01-30C16284748780-11030e365-5b4a-111a-e063-dadaa90a10e2Nabumetone Tablets, USP Rx only
71335-1234-22024-01-30C16284748780-11030e365-5b4a-111a-e063-dadaa90a10e2Nabumetone Tablets, USP Rx only
71335-1234-32024-01-30C16284748780-11030e365-5b4a-111a-e063-dadaa90a10e2Nabumetone Tablets, USP Rx only
71335-1234-42024-01-30C16284748780-11030e365-5b4a-111a-e063-dadaa90a10e2Nabumetone Tablets, USP Rx only
71335-1234-52024-01-30C16284748780-11030e365-5b4a-111a-e063-dadaa90a10e2Nabumetone Tablets, USP Rx only
71335-1234-62024-01-30C16284748780-11030e365-5b4a-111a-e063-dadaa90a10e2Nabumetone Tablets, USP Rx only
71335-1234-72024-01-30C16284748780-11030e365-5b4a-111a-e063-dadaa90a10e2Nabumetone Tablets, USP Rx only
71335-1234-82024-01-30C16284748780-11030e365-5b4a-111a-e063-dadaa90a10e2Nabumetone Tablets, USP Rx only
71335-1234-92024-01-30C16284748780-11030e365-5b4a-111a-e063-dadaa90a10e2Nabumetone Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1234-1Nabumetone20 in 1 BOTTLETABLET, FILM COATED205
71335-1234-2Nabumetone30 in 1 BOTTLETABLET, FILM COATED305
71335-1234-3Nabumetone60 in 1 BOTTLETABLET, FILM COATED605
71335-1234-4Nabumetone90 in 1 BOTTLETABLET, FILM COATED905
71335-1234-5Nabumetone42 in 1 BOTTLETABLET, FILM COATED425
71335-1234-6Nabumetone56 in 1 BOTTLETABLET, FILM COATED565
71335-1234-7Nabumetone14 in 1 BOTTLETABLET, FILM COATED145
71335-1234-8Nabumetone100 in 1 BOTTLETABLET, FILM COATED1005
71335-1234-9Nabumetone9 in 1 BOTTLETABLET, FILM COATED95

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1234-2EA - Each71335-1234d96f8bed-5ff0-430b-bed1-410c0ccd877d12020-09-14
71335-1234-3EA - Each71335-12340afad771-91b5-43c1-a772-ecfb3576043712019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1234NABUMETONE TABLET, FILM COATED [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 9 package rows20220513_dd0d2652-d335-45db-af43-5a2523f7299a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311892nabumetone 500 MG Oral TabletPSNdd0d2652-d335-45db-af43-5a2523f7299a5
311892nabumetone 500 MG Oral TabletSCDdd0d2652-d335-45db-af43-5a2523f7299a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1234-17133512340120 TABLET, FILM COATED in 1 BOTTLE (71335-1234-1) 2019-05-290000-00-00NoNoCurrent
71335-1234-27133512340230 TABLET, FILM COATED in 1 BOTTLE (71335-1234-2) 2019-10-220000-00-00NoNoCurrent
71335-1234-37133512340360 TABLET, FILM COATED in 1 BOTTLE (71335-1234-3) 2019-07-030000-00-00NoNoCurrent
71335-1234-47133512340490 TABLET, FILM COATED in 1 BOTTLE (71335-1234-4) 2019-06-190000-00-00NoNoCurrent
71335-1234-57133512340542 TABLET, FILM COATED in 1 BOTTLE (71335-1234-5) 2022-05-020000-00-00NoNoCurrent
71335-1234-67133512340656 TABLET, FILM COATED in 1 BOTTLE (71335-1234-6) 2019-07-150000-00-00NoNoCurrent
71335-1234-77133512340714 TABLET, FILM COATED in 1 BOTTLE (71335-1234-7) 2022-05-020000-00-00NoNoCurrent
71335-1234-871335123408100 TABLET, FILM COATED in 1 BOTTLE (71335-1234-8) 2022-05-020000-00-00NoNoCurrent
71335-1234-9713351234099 TABLET, FILM COATED in 1 BOTTLE (71335-1234-9) 2022-05-020000-00-00NoNoCurrent