FDA.reportPublic FDA data

Nabumetone

Product NDC
71205-978
11-digit product format
712050978
Labeler code
71205
Product ID
71205-978_40ce485f-575c-4c51-8058-83b10a8ddac7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nabumetone
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078420
Marketing category
ANDA
Marketing start
2019-09-25
Substance
NABUMETONE
Active strength
750 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
NABUMETONE750 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
71205-978-00Nabumetone100 in 1 BOTTLE, PLASTICTABLET1003
71205-978-30Nabumetone30 in 1 BOTTLE, PLASTICTABLET303
71205-978-55Nabumetone500 in 1 BOTTLE, PLASTICTABLET5003
71205-978-60Nabumetone60 in 1 BOTTLE, PLASTICTABLET603
71205-978-72Nabumetone120 in 1 BOTTLE, PLASTICTABLET1203
71205-978-90Nabumetone90 in 1 BOTTLE, PLASTICTABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-978-00EA - Each71205-9781446c3ff-9ba0-4b9d-80ba-985853ef7c5b12021-06-02
71205-978-30EA - Each71205-9783f529981-b411-4562-b2a1-281d3eb1ba1412021-06-02
71205-978-55EA - Each71205-978b02e1ff2-305f-4181-bc56-236bf3258b4e12021-06-02
71205-978-60EA - Each71205-978f067131a-5465-48ab-bff7-19935cff128112021-06-02
71205-978-72EA - Each71205-978f27001e7-274e-411c-9105-5818c9933d3912021-06-02
71205-978-90EA - Each71205-978df0e5b6f-514d-4c17-ad00-39109f0e8a4f12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-978NABUMETONE TABLET [PROFICIENT RX LP]3Current NDC, Legacy NDC, 6 package rows20220528_7a1643bf-6627-4b12-8246-6acc40517cf2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311892nabumetone 500 MG Oral TabletPSN7a1643bf-6627-4b12-8246-6acc40517cf23
311893nabumetone 750 MG Oral TabletPSN7a1643bf-6627-4b12-8246-6acc40517cf23
311892nabumetone 500 MG Oral TabletSCD7a1643bf-6627-4b12-8246-6acc40517cf23
311893nabumetone 750 MG Oral TabletSCD7a1643bf-6627-4b12-8246-6acc40517cf23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-978-0071205097800100 TABLET in 1 BOTTLE, PLASTIC (71205-978-00) 100 tablet2020-05-070000-00-00NoNoCurrent
71205-978-307120509783030 TABLET in 1 BOTTLE, PLASTIC (71205-978-30) 30 tablet2020-05-070000-00-00NoNoCurrent
71205-978-5571205097855500 TABLET in 1 BOTTLE, PLASTIC (71205-978-55) 500 tablet2020-05-070000-00-00NoNoCurrent
71205-978-607120509786060 TABLET in 1 BOTTLE, PLASTIC (71205-978-60) 60 tablet2020-05-070000-00-00NoNoCurrent
71205-978-7271205097872120 TABLET in 1 BOTTLE, PLASTIC (71205-978-72) 120 tablet2020-05-070000-00-00NoNoCurrent
71205-978-907120509789090 TABLET in 1 BOTTLE, PLASTIC (71205-978-90) 90 tablet2020-05-070000-00-00NoNoCurrent