Nabumetone

Product NDC
70518-4047
11-digit product format
705184047
Labeler code
70518
Product ID
70518-4047_4b8435b5-6dbd-c6cf-e063-6394a90aec8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nabumetone
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078420
Marketing category
ANDA
Marketing start
2024-04-07
Substance
NABUMETONE
Active strength
750 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
NABUMETONE750 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLW0TIW155Z
Rxcui311893

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
70518-4047-0Nabumetone14 in 1 BOTTLE, PLASTICTABLET144
70518-4047-1Nabumetone60 in 1 BOTTLE, PLASTICTABLET604
70518-4047-2Nabumetone60 in 1 BOTTLE, PLASTICTABLET604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4047NABUMETONE TABLET [REMEDYREPACK INC.]2Current NDC, 3 package rows20240517_6106afa3-e138-4b4d-8c13-992bf5062097.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311893nabumetone 750 MG Oral TabletPSN6106afa3-e138-4b4d-8c13-992bf50620974
311893nabumetone 750 MG Oral TabletSCD6106afa3-e138-4b4d-8c13-992bf50620974

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4047-07051840470014 TABLET in 1 BOTTLE, PLASTIC (70518-4047-0) 14 tablet2024-04-07NoNoCurrent
70518-4047-17051840470160 TABLET in 1 BOTTLE, PLASTIC (70518-4047-1) 60 tablet2024-05-16NoNoCurrent
70518-4047-27051840470260 TABLET in 1 BOTTLE, PLASTIC (70518-4047-2) 60 tablet2026-02-23NoNoCurrent