FDA.reportPublic FDA data

Nabumetone

Product NDC
0440-5843
11-digit product format
004405843
Labeler code
0440
Product ID
0440-5843_19c8dd72-b1a7-45bf-9d92-e756974a7b1c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nabumetone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Liberty Pharmaceuticals, Inc.
Application
ANDA078671
Marketing category
ANDA
Marketing start
2015-04-14
Marketing end
0000-00-00
Substance
NABUMETONE
Active strength
500 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
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
0440-5843-302020-01-31C16284748780-19d75b9d0-cffd-f424-e053-dadaa90a57ceNABUMETONE Tablet
0440-5843-812020-01-31C16284748780-19d75b9d0-cffd-f424-e053-dadaa90a57ceNABUMETONE Tablet
0440-5843-902020-01-31C16284748780-19d75b9d0-cffd-f424-e053-dadaa90a57ceNABUMETONE Tablet
0440-5843-922020-01-31C16284748780-19d75b9d0-cffd-f424-e053-dadaa90a57ceNABUMETONE Tablet
0440-5843-932020-01-31C16284748780-19d75b9d0-cffd-f424-e053-dadaa90a57ceNABUMETONE Tablet
0440-5843-952020-01-31C16284748780-19d75b9d0-cffd-f424-e053-dadaa90a57ceNABUMETONE Tablet

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0440-5843-30Nabumetone30 in 1 BOTTLETABLET, FILM COATED301
0440-5843-81Nabumetone300 in 1 BOTTLETABLET, FILM COATED3001
0440-5843-90Nabumetone90 in 1 BOTTLETABLET, FILM COATED901
0440-5843-92Nabumetone180 in 1 BOTTLETABLET, FILM COATED1801
0440-5843-93Nabumetone240 in 1 BOTTLETABLET, FILM COATED2401
0440-5843-95Nabumetone360 in 1 BOTTLETABLET, FILM COATED3601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0440-5843-30EA - Each0440-58434b05a331-f9c7-4866-a6cb-f6d11cb3e03b12018-04-19
0440-5843-81EA - Each0440-5843217e4b58-f3fa-403c-ae5f-2db81f0f2f7c12018-04-19
0440-5843-90EA - Each0440-584394d8f24f-d015-4aa2-97af-87ac2a99fa3b12018-04-19
0440-5843-92EA - Each0440-58438540d728-b422-4cef-a486-5413c10cbbbb12018-04-19
0440-5843-93EA - Each0440-584377547743-6e7e-4722-89eb-11ea493eb81912018-04-19
0440-5843-95EA - Each0440-584300d60987-a535-4b99-b43d-58f0f066b45112018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0440-5843NABUMETONE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1Legacy NDC, 6 package rows20160810_a79322ab-2af6-4d43-8548-85bfa3ea5e2c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311892nabumetone 500 MG Oral TabletPSNa79322ab-2af6-4d43-8548-85bfa3ea5e2c1
311893nabumetone 750 MG Oral TabletPSNa79322ab-2af6-4d43-8548-85bfa3ea5e2c1
311892nabumetone 500 MG Oral TabletSCDa79322ab-2af6-4d43-8548-85bfa3ea5e2c1
311893nabumetone 750 MG Oral TabletSCDa79322ab-2af6-4d43-8548-85bfa3ea5e2c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0440-5843-300044058433030 in 1 BOTTLEHistorical
0440-5843-8100440584381300 in 1 BOTTLEHistorical
0440-5843-900044058439090 in 1 BOTTLEHistorical
0440-5843-9200440584392180 in 1 BOTTLEHistorical
0440-5843-9300440584393240 in 1 BOTTLEHistorical
0440-5843-9500440584395360 in 1 BOTTLEHistorical