Nabumetone

Product NDC
45865-997
11-digit product format
458650997
Labeler code
45865
Product ID
45865-997_9af395be-165c-634d-e053-2995a90a072b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nabumetone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
medsource pharmaceuticals
Application
ANDA075189
Marketing category
ANDA
Marketing start
2001-09-26
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
2020-12-31
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
45865-997-602025-01-30C16284748780-12cef2736-689b-d83d-e063-dadaa90ab31fNABUMETONE TABLETS USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-997-60Nabumetone60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-997NABUMETONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 1 package rows20191231_9af36b29-ebc5-3148-e053-2995a90af655.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311893nabumetone 750 MG Oral TabletPSN9af36b29-ebc5-3148-e053-2995a90af6551
311893nabumetone 750 MG Oral TabletSCD9af36b29-ebc5-3148-e053-2995a90af6551

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-997-604586509976060 TABLET, FILM COATED in 1 BOTTLE (45865-997-60) 2019-12-110000-00-00NoNoCurrent