FDA.reportPublic FDA data

Nabumetone

Product NDC
50228-466
11-digit product format
502280466
Labeler code
50228
Product ID
50228-466_2b9b03ef-e03c-eca1-e063-6394a90a3fad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nabumetone
Dosage form
TABLET
Route
ORAL
Labeler
ScieGen Pharmaceuticals Inc
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
Rxcui311892, 311893

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
50228-466-01Nabumetone100 in 1 BOTTLETABLET1006
50228-466-05Nabumetone500 in 1 BOTTLETABLET5006
50228-466-30Nabumetone30 in 1 BOTTLETABLET306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-466-01EA - Each50228-466f59a501c-e15e-4ee5-bd96-9c123fcd542212019-08-06
50228-466-05EA - Each50228-4666d2de5e3-8213-44fb-8d09-29d4a015e38012019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-466NABUMETONE TABLET [SCIEGEN PHARMACEUTICALS INC]6Current NDC, Legacy NDC, 3 package rows20250115_80c6888d-03b4-44f3-b94d-bcf5154ceae5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311893nabumetone 750 MG Oral TabletPSN419c597f-6a6f-4420-b240-7dc4c223387e104
311893nabumetone 750 MG Oral TabletPSNa4553637-498e-491a-982a-cff81b43aa6c104
311893nabumetone 750 MG Oral TabletSCD419c597f-6a6f-4420-b240-7dc4c223387e104
311893nabumetone 750 MG Oral TabletSCDa4553637-498e-491a-982a-cff81b43aa6c104
311893nabumetone 750 MG Oral TabletPSNb2a41c0b-e2ad-4e14-a2f7-2049c12c35da103
311893nabumetone 750 MG Oral TabletSCDb2a41c0b-e2ad-4e14-a2f7-2049c12c35da103
311893nabumetone 750 MG Oral TabletPSN583602ff-dbbe-4369-afa9-b917734ac9b1101
311893nabumetone 750 MG Oral TabletPSN5a66c21f-4f06-4fb8-98fa-e81949586afd101
311893nabumetone 750 MG Oral TabletSCD583602ff-dbbe-4369-afa9-b917734ac9b1101
311893nabumetone 750 MG Oral TabletSCD5a66c21f-4f06-4fb8-98fa-e81949586afd101
311893nabumetone 750 MG Oral TabletPSN69620c53-b37a-45b9-b560-221bbcd98fda12
311893nabumetone 750 MG Oral TabletSCD69620c53-b37a-45b9-b560-221bbcd98fda12
311892nabumetone 500 MG Oral TabletPSNa8600b12-f180-0b27-e053-2995a90acbd911
311893nabumetone 750 MG Oral TabletPSNa8600b12-f180-0b27-e053-2995a90acbd911
311892nabumetone 500 MG Oral TabletSCDa8600b12-f180-0b27-e053-2995a90acbd911
311893nabumetone 750 MG Oral TabletSCDa8600b12-f180-0b27-e053-2995a90acbd911
311892nabumetone 500 MG Oral TabletPSN80c6888d-03b4-44f3-b94d-bcf5154ceae56
311893nabumetone 750 MG Oral TabletPSN80c6888d-03b4-44f3-b94d-bcf5154ceae56
311893nabumetone 750 MG Oral TabletPSNb43db4aa-6013-3942-e053-2a95a90a51896
311892nabumetone 500 MG Oral TabletSCD80c6888d-03b4-44f3-b94d-bcf5154ceae56
311893nabumetone 750 MG Oral TabletSCD80c6888d-03b4-44f3-b94d-bcf5154ceae56
311893nabumetone 750 MG Oral TabletSCDb43db4aa-6013-3942-e053-2a95a90a51896
311893nabumetone 750 MG Oral TabletPSNd997d125-dfc5-4cc5-b7a6-03f5a7248d145
311893nabumetone 750 MG Oral TabletPSNda259c7c-6f1e-403c-b42b-596d53b61fe55
311893nabumetone 750 MG Oral TabletPSNda34003b-81a4-2efd-e053-2995a90a961c5
311893nabumetone 750 MG Oral TabletPSN455c9992-39a0-4353-a121-57e700c779425
311893nabumetone 750 MG Oral TabletSCDd997d125-dfc5-4cc5-b7a6-03f5a7248d145
311893nabumetone 750 MG Oral TabletSCD455c9992-39a0-4353-a121-57e700c779425
311893nabumetone 750 MG Oral TabletSCDda259c7c-6f1e-403c-b42b-596d53b61fe55
311893nabumetone 750 MG Oral TabletSCDda34003b-81a4-2efd-e053-2995a90a961c5
311893nabumetone 750 MG Oral TabletPSN94930125-b792-579e-e053-2995a90ab6f94
311893nabumetone 750 MG Oral TabletPSN6106afa3-e138-4b4d-8c13-992bf50620974
311893nabumetone 750 MG Oral TabletSCD94930125-b792-579e-e053-2995a90ab6f94
311893nabumetone 750 MG Oral TabletSCD6106afa3-e138-4b4d-8c13-992bf50620974
311893nabumetone 750 MG Oral TabletPSN75c51686-9c5e-4c13-acf4-2d04502eedda2
311893nabumetone 750 MG Oral TabletPSNf4392863-ed3f-4fbd-8260-49827609aa2e2
311893nabumetone 750 MG Oral TabletSCD75c51686-9c5e-4c13-acf4-2d04502eedda2
311893nabumetone 750 MG Oral TabletSCDf4392863-ed3f-4fbd-8260-49827609aa2e2
311893nabumetone 750 MG Oral TabletPSNb523da6c-bd32-7f41-e053-2995a90afc6a1
311893nabumetone 750 MG Oral TabletSCDb523da6c-bd32-7f41-e053-2995a90afc6a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50228-466-0150228046601100 TABLET in 1 BOTTLE (50228-466-01) 100 tablet2019-06-260000-00-00NoNoCurrent
50228-466-0550228046605500 TABLET in 1 BOTTLE (50228-466-05) 500 tablet2019-06-260000-00-00NoNoCurrent
50228-466-305022804663030 TABLET in 1 BOTTLE (50228-466-30) 30 tablet2019-06-260000-00-00NoNoCurrent