Nabumetone

Product NDC
80425-0053
11-digit product format
804250053
Labeler code
80425
Product ID
80425-0053_2a98d9c1-b76e-40b1-e063-6294a90a20e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nabumetone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA078671
Marketing category
ANDA
Marketing start
2019-03-06
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nabumetone
Listing expiration
2026-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0053-1Nabumetone60 in 1 BOTTLETABLET, FILM COATED605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0053-1EA - Each80425-0053a4e8ad19-70dc-4c47-9cf5-d9df2892889a12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0053NABUMETONE TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC]5Current NDC, Legacy NDC, 1 package rows20250101_af9969df-ce14-c0bc-e053-2995a90a3f59.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311892nabumetone 500 MG Oral TabletPSNaf9969df-ce14-c0bc-e053-2995a90a3f595
311892nabumetone 500 MG Oral TabletSCDaf9969df-ce14-c0bc-e053-2995a90a3f595

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80425-0053-18042500530160 TABLET, FILM COATED in 1 BOTTLE (80425-0053-1) 2019-03-060000-00-00NoNoCurrent