Nabumetone

Product NDC
43063-972
11-digit product format
430630972
Labeler code
43063
Product ID
43063-972_36c31358-008c-bd73-e063-6294a90a06cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nabumetone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, 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

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
43063-972-20Nabumetone20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2010
43063-972-30Nabumetone30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-972-20EA - Each43063-9723a555ac3-62eb-45d6-bd16-f8278752ef3a12019-06-19
43063-972-30EA - Each43063-9729a27a891-9b50-46a1-a22b-9eaa7ef3925212019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-972NABUMETONE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 2 package rows20241018_8f3c1b1d-2765-4cb5-92df-044b99339c92.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-972-204306309722020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-972-20) 2019-04-220000-00-00NoNoCurrent
43063-972-304306309723030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-972-30) 2019-07-100000-00-00NoNoCurrent