Nabumetone

Product NDC
63629-8506
11-digit product format
636298506
Labeler code
63629
Product ID
63629-8506_3eeeed3c-83bd-483c-81ea-b73b049ad3c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nabumetone
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078420
Marketing category
ANDA
Marketing start
2019-06-26
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

openFDA Listing Details

Product ID
63629-8506_3eeeed3c-83bd-483c-81ea-b73b049ad3c8
Product type
HUMAN PRESCRIPTION DRUG
Finished product
Yes
Brand name base
Nabumetone
Generic name
Nabumetone
Dosage form
TABLET
Route
ORAL
Marketing start
2019-06-26
Marketing category
ANDA
Application number
ANDA078420
Pharmacologic classes
Anti-Inflammatory Agents; Non-Steroidal [CS]; Cyclooxygenase Inhibitors [MoA]; Nonsteroidal Anti-inflammatory Drug [EPC]
Listing expiration
2026-12-31

Related Records

openFDA Active Ingredients

IngredientStrength
NABUMETONE500 mg/1

openFDA Harmonized Identifiers

FieldValues
UniiLW0TIW155Z
Rxcui311892
Spl Set Id0be7ee60-2706-43ed-98ec-b89cd4e2b57c
Manufacturer NameBryant Ranch Prepack

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
LW0TIW155ZNABUMETONE42924-53-8NABUMETONE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8506-163629850601500 TABLET in 1 BOTTLE (63629-8506-1) 500 tablet2019-06-260000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
NABUMETONE TABLETS USP Rx OnlyBryant Ranch Prepack2025-03-26HUMAN PRESCRIPTION DRUG LABEL104