FDA.reportPublic FDA data

Nabumetone

Product NDC
0440-5844
11-digit product format
004405844
Labeler code
0440
Product ID
0440-5844_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
750 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
0440-5844-052020-01-31C16284748780-19d75b9d0-cffd-f424-e053-dadaa90a57ceNABUMETONE Tablet
0440-5844-302020-01-31C16284748780-19d75b9d0-cffd-f424-e053-dadaa90a57ceNABUMETONE Tablet
0440-5844-812020-01-31C16284748780-19d75b9d0-cffd-f424-e053-dadaa90a57ceNABUMETONE Tablet
0440-5844-902020-01-31C16284748780-19d75b9d0-cffd-f424-e053-dadaa90a57ceNABUMETONE Tablet
0440-5844-912020-01-31C16284748780-19d75b9d0-cffd-f424-e053-dadaa90a57ceNABUMETONE Tablet
0440-5844-922020-01-31C16284748780-19d75b9d0-cffd-f424-e053-dadaa90a57ceNABUMETONE Tablet

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0440-5844-05Nabumetone500 in 1 BOTTLETABLET, FILM COATED5001
0440-5844-30Nabumetone30 in 1 BOTTLETABLET, FILM COATED301
0440-5844-81Nabumetone300 in 1 BOTTLETABLET, FILM COATED3001
0440-5844-90Nabumetone90 in 1 BOTTLETABLET, FILM COATED901
0440-5844-91Nabumetone120 in 1 BOTTLETABLET, FILM COATED1201
0440-5844-92Nabumetone180 in 1 BOTTLETABLET, FILM COATED1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0440-5844-05EA - Each0440-5844a5f39a0e-a6e4-41f4-b2b3-e640ae8ed7b212018-04-19
0440-5844-30EA - Each0440-58445fc98593-3d91-4a96-9f2a-598e4bae90ef12018-04-19
0440-5844-81EA - Each0440-58446fd39b4e-3129-40c5-82a9-da0f9e037aa712018-04-19
0440-5844-90EA - Each0440-5844110cb8ff-1ad3-4308-959f-64377f0299bf12018-04-19
0440-5844-91EA - Each0440-5844daf8d97d-1466-40bd-b067-d2d80d72f4ad12018-04-19
0440-5844-92EA - Each0440-5844e0e2e214-eb10-49e9-aa0a-22c78725203e12018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0440-5844NABUMETONE 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
0440-5844-0500440584405500 in 1 BOTTLEHistorical
0440-5844-300044058443030 in 1 BOTTLEHistorical
0440-5844-8100440584481300 in 1 BOTTLEHistorical
0440-5844-900044058449090 in 1 BOTTLEHistorical
0440-5844-9100440584491120 in 1 BOTTLEHistorical
0440-5844-9200440584492180 in 1 BOTTLEHistorical