Nabumetone

Product NDC
0115-1658
11-digit product format
001151658
Labeler code
0115
Product ID
0115-1658_e904ba7b-549f-43cb-aafb-ffc109a4d227
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nabumetone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
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
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
0115-1658-012023-01-30C16284748780-1f386c64a-08d1-0266-e053-dadaa90a7c1aNABUMETONE TABLETS USP Rx Only
0115-1658-032023-01-30C16284748780-1f386c64a-08d1-0266-e053-dadaa90a7c1aNABUMETONE TABLETS USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0115-1658-01Nabumetone100 in 1 BOTTLETABLET, FILM COATED10013
0115-1658-03Nabumetone1000 in 1 BOTTLETABLET, FILM COATED100013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-1658-01EA - Each0115-1658afa2b702-779f-4e8f-8826-345dead0b29412017-03-06
0115-1658-03EA - Each0115-1658dd5e0f64-2be8-4f8d-ad64-a2cfda00fd8812017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-1658NABUMETONE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]13Legacy NDC, 2 package rows20201230_7b547af0-7be4-4277-8064-1bf1925154bb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311892nabumetone 500 MG Oral TabletPSN7b547af0-7be4-4277-8064-1bf1925154bb13
311893nabumetone 750 MG Oral TabletPSN7b547af0-7be4-4277-8064-1bf1925154bb13
311892nabumetone 500 MG Oral TabletSCD7b547af0-7be4-4277-8064-1bf1925154bb13
311893nabumetone 750 MG Oral TabletSCD7b547af0-7be4-4277-8064-1bf1925154bb13
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
0115-1658-0100115165801100 TABLET, FILM COATED in 1 BOTTLE (0115-1658-01) 2001-09-260000-00-00NoNoCurrent
0115-1658-03001151658031000 TABLET, FILM COATED in 1 BOTTLE (0115-1658-03) 2001-09-260000-00-00NoNoCurrent