Nabumetone

Product NDC
70518-3835
11-digit product format
705183835
Labeler code
70518
Product ID
70518-3835_3f68d0c6-26a6-df70-e063-6294a90a1f75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nabumetone
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078420
Marketing category
ANDA
Marketing start
2023-08-18
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
LW0TIW155ZNABUMETONE42924-53-8NABUMETONE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3835-07051838350014 TABLET in 1 BOTTLE, PLASTIC (70518-3835-0) 14 tablet2023-08-18NoNoHistorical
70518-3835-17051838350160 TABLET in 1 BOTTLE, PLASTIC (70518-3835-1) 60 tablet2024-03-12NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
NABUMETONE TABLETS USP Rx OnlyREMEDYREPACK INC.2025-09-22HUMAN PRESCRIPTION DRUG LABEL3