FDA.reportPublic FDA data

Nabumetone

Product NDC
72162-1557
11-digit product format
721621557
Labeler code
72162
Product ID
72162-1557_c8232f1d-ead4-4e07-9731-dd0b9265f736
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

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
72162-1557-1Nabumetone100 in 1 BOTTLETABLET100101
72162-1557-5Nabumetone500 in 1 BOTTLETABLET500101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1557-1EA - Each72162-155734e53a28-290a-46d0-9540-387b1a5e8da312024-04-05
72162-1557-5EA - Each72162-155746f7494d-4c15-4062-8597-7f868252a26012024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1557NABUMETONE TABLET [BRYANT RANCH PREPACK]101Current NDC, 2 package rows20250403_ad9f2a34-6244-49b7-98ee-af18cb55693c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311892nabumetone 500 MG Oral TabletPSNad9f2a34-6244-49b7-98ee-af18cb55693c101
311892nabumetone 500 MG Oral TabletSCDad9f2a34-6244-49b7-98ee-af18cb55693c101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1557-172162155701100 TABLET in 1 BOTTLE (72162-1557-1) 100 tablet2024-02-08NoNoCurrent
72162-1557-572162155705500 TABLET in 1 BOTTLE (72162-1557-5) 500 tablet2024-02-08NoNoCurrent