Nabumetone 750 mg

Product NDC
0722-7077
11-digit product format
007227077
Labeler code
0722
Product ID
0722-7077_e30d19de-6b96-45a9-9c47-1d13cdbd10ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nabumetone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Nexgen Pharma, Inc.
Application
ANDA203166
Marketing category
ANDA
Marketing start
2019-09-04
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
0722-7077-012021-01-29C16284748780-1ba0f9c33-2812-a910-e053-dadaa90a0b85NABUMETONE TABLETS USP Rx Only
0722-7077-052021-01-29C16284748780-1ba0f9c33-2812-a910-e053-dadaa90a0b85NABUMETONE TABLETS USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0722-7077-01Nabumetone 750 mg100 in 1 BOTTLETABLET, FILM COATED1006
0722-7077-05Nabumetone 750 mg500 in 1 BOTTLETABLET, FILM COATED5006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0722-7077NABUMETONE 500 MG (NABUMETONE) TABLET, FILM COATED NABUMETONE 750 MG (NABUMETONE) TABLET, FILM COATED NABUMETONE 1000 MG (NABUMETONE) TABLET, FILM COATED [NEXGEN PHARMA, INC.]6Legacy NDC, 2 package rows20190928_0d5a5b1c-e3a7-4f90-a457-0fb6f44dbc8d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
427726nabumetone 1000 MG Oral TabletPSN0d5a5b1c-e3a7-4f90-a457-0fb6f44dbc8d6
311892nabumetone 500 MG Oral TabletPSN0d5a5b1c-e3a7-4f90-a457-0fb6f44dbc8d6
311893nabumetone 750 MG Oral TabletPSN0d5a5b1c-e3a7-4f90-a457-0fb6f44dbc8d6
427726nabumetone 1000 MG Oral TabletSCD0d5a5b1c-e3a7-4f90-a457-0fb6f44dbc8d6
311892nabumetone 500 MG Oral TabletSCD0d5a5b1c-e3a7-4f90-a457-0fb6f44dbc8d6
311893nabumetone 750 MG Oral TabletSCD0d5a5b1c-e3a7-4f90-a457-0fb6f44dbc8d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0722-7077-0100722707701100 in 1 BOTTLEHistorical
0722-7077-0500722707705500 in 1 BOTTLEHistorical