Nabumetone

Product NDC
45865-111
11-digit product format
458650111
Labeler code
45865
Product ID
45865-111_b523dbfe-898f-c75b-e053-2a95a90a7ea2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nabumetone
Dosage form
TABLET
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA078420
Marketing category
ANDA
Marketing start
2020-07-01
Marketing end
0000-00-00
Substance
NABUMETONE
Active strength
750 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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
45865-111-602025-01-30C16284748780-12cef2736-66eb-d83d-e063-dadaa90ab31fNabumetone Tablets USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-111-60Nabumetone60 in 1 BOTTLETABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-111NABUMETONE TABLET [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 1 package rows20201128_b523da6c-bd32-7f41-e053-2995a90afc6a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311893nabumetone 750 MG Oral TabletPSNb523da6c-bd32-7f41-e053-2995a90afc6a1
311893nabumetone 750 MG Oral TabletSCDb523da6c-bd32-7f41-e053-2995a90afc6a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-111-604586501116060 TABLET in 1 BOTTLE (45865-111-60) 60 tablet2020-07-010000-00-00NoNoCurrent