FDA.reportPublic FDA data

Nabumetone

Product NDC
50090-5294
11-digit product format
500905294
Labeler code
50090
Product ID
50090-5294_f0e0931b-cf9a-41d0-8497-c4275f59c894
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nabumetone
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5294-02023-02-06C16284748780-1f386c64a-2209-0266-e053-dadaa90a7c1aNABUMETONE TABLETS USP Rx Only
50090-5294-42023-02-06C16284748780-1f386c64a-2209-0266-e053-dadaa90a7c1aNABUMETONE TABLETS USP Rx Only
50090-5294-52023-02-06C16284748780-1f386c64a-2209-0266-e053-dadaa90a7c1aNABUMETONE TABLETS USP Rx Only
50090-5294-72023-02-06C16284748780-1f386c64a-2209-0266-e053-dadaa90a7c1aNABUMETONE TABLETS USP Rx Only
50090-5294-82023-02-06C16284748780-1f386c64a-2209-0266-e053-dadaa90a7c1aNABUMETONE TABLETS USP Rx Only
50090-5294-02023-01-30C16284748780-1f386c64a-2209-0266-e053-dadaa90a7c1aNABUMETONE TABLETS USP Rx Only
50090-5294-42023-01-30C16284748780-1f386c64a-2209-0266-e053-dadaa90a7c1aNABUMETONE TABLETS USP Rx Only
50090-5294-52023-01-30C16284748780-1f386c64a-2209-0266-e053-dadaa90a7c1aNABUMETONE TABLETS USP Rx Only
50090-5294-72023-01-30C16284748780-1f386c64a-2209-0266-e053-dadaa90a7c1aNABUMETONE TABLETS USP Rx Only
50090-5294-82023-01-30C16284748780-1f386c64a-2209-0266-e053-dadaa90a7c1aNABUMETONE TABLETS USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5294-0Nabumetone60 in 1 BOTTLETABLET609
50090-5294-4Nabumetone14 in 1 BOTTLETABLET149
50090-5294-5Nabumetone20 in 1 BOTTLETABLET209
50090-5294-7Nabumetone30 in 1 BOTTLETABLET309
50090-5294-8Nabumetone90 in 1 BOTTLETABLET909

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5294NABUMETONE TABLET [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 5 package rows20241115_26037234-daca-4f1a-a7a7-0871f77283f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311892nabumetone 500 MG Oral TabletPSN26037234-daca-4f1a-a7a7-0871f77283f09
311892nabumetone 500 MG Oral TabletSCD26037234-daca-4f1a-a7a7-0871f77283f09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5294-05009052940060 TABLET in 1 BOTTLE (50090-5294-0) 60 tablet2020-10-230000-00-00NoNoCurrent
50090-5294-45009052940414 TABLET in 1 BOTTLE (50090-5294-4) 14 tablet2020-10-230000-00-00NoNoCurrent
50090-5294-55009052940520 TABLET in 1 BOTTLE (50090-5294-5) 20 tablet2020-10-230000-00-00NoNoCurrent
50090-5294-75009052940730 TABLET in 1 BOTTLE (50090-5294-7) 30 tablet2020-10-230000-00-00NoNoCurrent
50090-5294-85009052940890 TABLET in 1 BOTTLE (50090-5294-8) 90 tablet2020-10-230000-00-00NoNoCurrent