Nabumetone

Product NDC
51655-396
11-digit product format
516550396
Labeler code
51655
Product ID
51655-396_48fee402-9a88-b9ec-e063-6394a90add0c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nabumetone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA078671
Marketing category
ANDA
Marketing start
2020-07-07
Substance
NABUMETONE
Active strength
500 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nabumetone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NABUMETONE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLW0TIW155Z
Rxcui311892

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
51655-396-252023-10-30C16284748780-1f386c649-c9a0-0266-e053-dadaa90a7c1ab088f564-43ff-8007-e053-2995a90ab012
51655-396-252023-01-30C16284748780-1f386c649-c9a0-0266-e053-dadaa90a7c1ab088f564-43ff-8007-e053-2995a90ab012

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-396-25Nabumetone60 in 1 BOTTLE, PLASTICTABLET, FILM COATED604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-396NABUMETONE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, Legacy NDC, 1 package rows20231031_b088f564-43ff-8007-e053-2995a90ab012.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311892nabumetone 500 MG Oral TabletPSNb088f564-43ff-8007-e053-2995a90ab0124
311892nabumetone 500 MG Oral TabletSCDb088f564-43ff-8007-e053-2995a90ab0124

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51655-396-255165503962560 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-396-25) 2020-07-070000-00-00NoNoCurrent