FDA.reportPublic FDA data

Nabumetone

Product NDC
76420-210
11-digit product format
764200210
Labeler code
76420
Product ID
76420-210_d9ae8825-f28b-ba4e-e053-2995a90a4487
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nabumetone
Dosage form
TABLET
Route
ORAL
Labeler
Asclemed USA, Inc.
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
76420-210-07Nabumetone7 in 1 BOTTLETABLET71
76420-210-10Nabumetone10 in 1 BOTTLETABLET101
76420-210-14Nabumetone14 in 1 BOTTLETABLET141
76420-210-20Nabumetone20 in 1 BOTTLETABLET201
76420-210-30Nabumetone30 in 1 BOTTLETABLET301
76420-210-60Nabumetone60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-210-07EA - Each76420-21016f1bc37-9fc6-4cfa-b1d7-ba8460540e8c12022-04-06
76420-210-10EA - Each76420-210a98c63fb-b2da-45b0-b886-2d6996c8888112022-04-06
76420-210-14EA - Each76420-210a02a2d57-9c40-4212-a423-6411c877e13712022-04-06
76420-210-20EA - Each76420-21022bef80d-5446-464b-a949-8e23a9c8018412022-04-06
76420-210-30EA - Each76420-2106d40ebdd-be9e-452a-a5da-773db9f4f64912022-04-06
76420-210-60EA - Each76420-2103a4d6525-badd-4947-81bf-38196737b03912022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-210NABUMETONE TABLET [ASCLEMED USA, INC.]1Current NDC, Legacy NDC, 6 package rows20220308_04a71deb-2c9d-436c-a574-e5991b6a5248.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311892nabumetone 500 MG Oral TabletPSN04a71deb-2c9d-436c-a574-e5991b6a52481
311892nabumetone 500 MG Oral TabletSCD04a71deb-2c9d-436c-a574-e5991b6a52481

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-210-07764200210077 TABLET in 1 BOTTLE (76420-210-07) 7 tablet2022-03-080000-00-00NoNoCurrent
76420-210-107642002101010 TABLET in 1 BOTTLE (76420-210-10) 10 tablet2022-03-080000-00-00NoNoCurrent
76420-210-147642002101414 TABLET in 1 BOTTLE (76420-210-14) 14 tablet2022-03-080000-00-00NoNoCurrent
76420-210-207642002102020 TABLET in 1 BOTTLE (76420-210-20) 20 tablet2022-03-080000-00-00NoNoCurrent
76420-210-307642002103030 TABLET in 1 BOTTLE (76420-210-30) 30 tablet2022-03-080000-00-00NoNoCurrent
76420-210-607642002106060 TABLET in 1 BOTTLE (76420-210-60) 60 tablet2022-03-080000-00-00NoNoCurrent