FDA.reportPublic FDA data

Nabumetone

Product NDC
50090-0800
11-digit product format
500900800
Labeler code
50090
Product ID
50090-0800_f0b56baf-2fd9-4115-ba2b-b71904360e8e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nabumetone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091083
Marketing category
ANDA
Marketing start
2011-06-13
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
2022-12-31
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
50090-0800-02023-01-30C16284748780-1f386c649-c19c-0266-e053-dadaa90a7c1aNabumetone Tablets, USP Rx Only
50090-0800-22023-01-30C16284748780-1f386c649-c19c-0266-e053-dadaa90a7c1aNabumetone Tablets, USP Rx Only
50090-0800-32023-01-30C16284748780-1f386c649-c19c-0266-e053-dadaa90a7c1aNabumetone Tablets, USP Rx Only
50090-0800-42023-01-30C16284748780-1f386c649-c19c-0266-e053-dadaa90a7c1aNabumetone Tablets, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0800-0Nabumetone30 in 1 BOTTLETABLET, FILM COATED3014
50090-0800-2Nabumetone14 in 1 BOTTLETABLET, FILM COATED1414
50090-0800-3Nabumetone60 in 1 BOTTLETABLET, FILM COATED6014
50090-0800-4Nabumetone20 in 1 BOTTLETABLET, FILM COATED2014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0800-0EA - Each50090-08008367b58a-c77a-46ed-b528-f5966fbd517c12018-10-11
50090-0800-2EA - Each50090-0800b6de8b37-e7ee-4406-8fbd-55f04bee824712018-10-11
50090-0800-3EA - Each50090-080075ee1d68-0399-4e56-9461-0eef7537d85512018-10-11
50090-0800-4EA - Each50090-0800b489d53b-2b76-44f5-932b-abe87554bf7812018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0800NABUMETONE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]14Legacy NDC, 4 package rows20210616_466f4261-4b7c-4502-9f00-8d0c7e46ac89.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311893nabumetone 750 MG Oral TabletPSN466f4261-4b7c-4502-9f00-8d0c7e46ac8914
311893nabumetone 750 MG Oral TabletSCD466f4261-4b7c-4502-9f00-8d0c7e46ac8914

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0800-05009008000030 TABLET, FILM COATED in 1 BOTTLE (50090-0800-0) 2014-11-280000-00-00NoNoCurrent
50090-0800-25009008000214 TABLET, FILM COATED in 1 BOTTLE (50090-0800-2) 2014-11-280000-00-00NoNoCurrent
50090-0800-35009008000360 TABLET, FILM COATED in 1 BOTTLE (50090-0800-3) 2014-11-280000-00-00NoNoCurrent
50090-0800-45009008000420 TABLET, FILM COATED in 1 BOTTLE (50090-0800-4) 2014-11-280000-00-00NoNoCurrent