FDA.reportPublic FDA data

Nabumetone

Product NDC
69097-965
11-digit product format
690970965
Labeler code
69097
Product ID
69097-965_46daea72-1c6d-41ce-b8d0-c412ca0d908e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nabumetone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA078671
Marketing category
ANDA
Marketing start
2019-03-06
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, 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
69097-965-07Nabumetone100 in 1 BOTTLETABLET, FILM COATED1004
69097-965-12Nabumetone500 in 1 BOTTLETABLET, FILM COATED5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-965-07EA - Each69097-9656282fee7-d4b4-41ea-b876-1a2c0e28671212019-04-11
69097-965-12EA - Each69097-9657da349af-29b5-43ee-af8c-3bb5ef1cda8b12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-965NABUMETONE TABLET, FILM COATED [CIPLA USA INC.]4Current NDC, Legacy NDC, 2 package rows20250410_85954380-a520-46d7-89ac-e4b19d6e00a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311892nabumetone 500 MG Oral TabletPSN8f3c1b1d-2765-4cb5-92df-044b99339c9210
311892nabumetone 500 MG Oral TabletSCD8f3c1b1d-2765-4cb5-92df-044b99339c9210
311892nabumetone 500 MG Oral TabletPSN0653b873-b74b-4ec6-b112-675760703d915
311892nabumetone 500 MG Oral TabletPSNaf9969df-ce14-c0bc-e053-2995a90a3f595
311892nabumetone 500 MG Oral TabletSCD0653b873-b74b-4ec6-b112-675760703d915
311892nabumetone 500 MG Oral TabletSCDaf9969df-ce14-c0bc-e053-2995a90a3f595
311892nabumetone 500 MG Oral TabletPSN85954380-a520-46d7-89ac-e4b19d6e00a14
311892nabumetone 500 MG Oral TabletPSNb088f564-43ff-8007-e053-2995a90ab0124
311893nabumetone 750 MG Oral TabletPSN85954380-a520-46d7-89ac-e4b19d6e00a14
311892nabumetone 500 MG Oral TabletSCD85954380-a520-46d7-89ac-e4b19d6e00a14
311892nabumetone 500 MG Oral TabletSCDb088f564-43ff-8007-e053-2995a90ab0124
311893nabumetone 750 MG Oral TabletSCD85954380-a520-46d7-89ac-e4b19d6e00a14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69097-965-0769097096507100 TABLET, FILM COATED in 1 BOTTLE (69097-965-07) 2019-03-060000-00-00NoNoCurrent
69097-965-1269097096512500 TABLET, FILM COATED in 1 BOTTLE (69097-965-12) 2019-03-060000-00-00NoNoCurrent