Nabumetone

Product NDC
63187-484
11-digit product format
631870484
Labeler code
63187
Product ID
63187-484_51b7f2a3-4f74-4074-b871-dc1479083282
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nabumetone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078671
Marketing category
ANDA
Marketing start
2008-03-01
Marketing end
0000-00-00
Substance
NABUMETONE
Active strength
500 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-484-14EA - Each63187-4842d78eeeb-346d-47d6-90b2-02a1d034778c12019-04-11
63187-484-30EA - Each63187-48442672f1b-849f-4580-9220-9bb49e231a1212016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NABUMETONEACTIVE INGREDIENTLW0TIW155ZNABUMETONE TABLET, FILM COATED [PROFICIENT RX LP]1
NABUMETONEACTIVE MOIETYLW0TIW155ZNABUMETONE TABLET, FILM COATED [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNABUMETONE TABLET, FILM COATED [PROFICIENT RX LP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONABUMETONE TABLET, FILM COATED [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NABUMETONE TABLET, FILM COATED [PROFICIENT RX LP]1
POLYETHYLENE GLYCOL 200INACTIVE INGREDIENTR95B8J264JNABUMETONE TABLET, FILM COATED [PROFICIENT RX LP]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HNABUMETONE TABLET, FILM COATED [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NABUMETONE TABLET, FILM COATED [PROFICIENT RX LP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNABUMETONE TABLET, FILM COATED [PROFICIENT RX LP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2NABUMETONE TABLET, FILM COATED [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNABUMETONE TABLET, FILM COATED [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-484NABUMETONE TABLET, FILM COATED [PROFICIENT RX LP]5Legacy NDC20210114_c774b1d0-a2cc-4916-9cca-418c56af15d0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-484-146318704841414 TABLET, FILM COATED in 1 BOTTLE (63187-484-14) 2019-01-010000-00-00NoNoCurrent
63187-484-306318704843030 TABLET, FILM COATED in 1 BOTTLE (63187-484-30) 2015-02-020000-00-00NoNoCurrent
63187-484-606318704846060 TABLET, FILM COATED in 1 BOTTLE (63187-484-60) 2015-02-020000-00-00NoNoCurrent
63187-484-906318704849090 TABLET, FILM COATED in 1 BOTTLE (63187-484-90) 2015-02-020000-00-00NoNoCurrent