FDA.reportPublic FDA data

Nabumetone

Product NDC
72162-1558
11-digit product format
721621558
Labeler code
72162
Product ID
72162-1558_7e68dda2-0495-4f20-9bb6-19b2eb38d3c7
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
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
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
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
72162-1558-1Nabumetone100 in 1 BOTTLETABLET100101
72162-1558-5Nabumetone500 in 1 BOTTLETABLET500101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1558-1EA - Each72162-15585e269120-9f7e-481c-b0fb-5143982b455212024-04-05
72162-1558-5EA - Each72162-15587322f52d-db1c-4170-90e8-c4b5d5d6e47712024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1558NABUMETONE TABLET [BRYANT RANCH PREPACK]101Current NDC, 2 package rows20250403_583602ff-dbbe-4369-afa9-b917734ac9b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311893nabumetone 750 MG Oral TabletPSN583602ff-dbbe-4369-afa9-b917734ac9b1101
311893nabumetone 750 MG Oral TabletSCD583602ff-dbbe-4369-afa9-b917734ac9b1101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1558-172162155801100 TABLET in 1 BOTTLE (72162-1558-1) 100 tablet2024-02-08NoNoHistorical
72162-1558-572162155805500 TABLET in 1 BOTTLE (72162-1558-5) 500 tablet2024-02-08NoNoHistorical