FDA.reportPublic FDA data

Nabumetone

Product NDC
71205-030
11-digit product format
712050030
Labeler code
71205
Product ID
71205-030_55d8ea63-038a-4294-9243-ca915460c1a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nabumetone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA091083
Marketing category
ANDA
Marketing start
2011-06-13
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-030-20Nabumetone20 in 1 BOTTLE, PLASTICTABLET, FILM COATED205
71205-030-30Nabumetone30 in 1 BOTTLE, PLASTICTABLET, FILM COATED305
71205-030-60Nabumetone60 in 1 BOTTLE, PLASTICTABLET, FILM COATED605
71205-030-90Nabumetone90 in 1 BOTTLE, PLASTICTABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-030-20EA - Each71205-03034ad6566-1f36-4427-b245-7e2db421179112022-05-04
71205-030-30EA - Each71205-030367d2a0d-7354-40ad-be62-e33d6a9b36f612018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-030NABUMETONE TABLET, FILM COATED [PROFICIENT RX LP]5Current NDC, Legacy NDC, 4 package rows20221211_0870c3c9-bfce-4722-8779-8775644196d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311892nabumetone 500 MG Oral TabletPSN0870c3c9-bfce-4722-8779-8775644196d35
311892nabumetone 500 MG Oral TabletSCD0870c3c9-bfce-4722-8779-8775644196d35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-030-207120500302020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-030-20) 2022-01-190000-00-00NoNoCurrent
71205-030-307120500303030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-030-30) 2018-05-010000-00-00NoNoCurrent
71205-030-607120500306060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-030-60) 2018-05-010000-00-00NoNoCurrent
71205-030-907120500309090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-030-90) 2018-05-010000-00-00NoNoCurrent