Nabumetone

Product NDC
63874-687
11-digit product format
638740687
Labeler code
63874
Product ID
63874-687_c445da39-f7f2-46a9-871f-a25f1c0f462f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nabumetone
Dosage form
TABLET
Route
ORAL
Labeler
Altura Pharmaceuticals, Inc.
Application
ANDA076009
Marketing category
ANDA
Marketing start
2010-01-01
Marketing end
0000-00-00
Substance
NABUMETONE
Active strength
750 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9d4d18c4-d38e-37e1-df1c-ee38762bf8a5Product name420251024

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63874-687-01Nabumetone100 in 1 BOTTLE, PLASTICTABLET1002
63874-687-30Nabumetone30 in 1 BOTTLE, PLASTICTABLET302
63874-687-60Nabumetone60 in 1 BOTTLE, PLASTICTABLET602
63874-687-90Nabumetone90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63874-687-01EA - Each63874-687c7ba721b-73db-4b5b-b27b-18f18962a36f12012-07-24
63874-687-30EA - Each63874-687359e055e-0db4-45ef-86ad-f6872a94eb3612015-10-02
63874-687-60EA - Each63874-687e555ae29-0bb8-4871-b97e-036fc143388e12012-07-24
63874-687-90EA - Each63874-687c681c275-1b2b-48f6-b084-8d9d8962c4b912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NABUMETONEACTIVE INGREDIENTLW0TIW155ZNABUMETONE TABLET [ALTURA PHARMACEUTICALS, INC.]2
NABUMETONEACTIVE MOIETYLW0TIW155ZNABUMETONE TABLET [ALTURA PHARMACEUTICALS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNABUMETONE TABLET [ALTURA PHARMACEUTICALS, INC.]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NABUMETONE TABLET [ALTURA PHARMACEUTICALS, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNABUMETONE TABLET [ALTURA PHARMACEUTICALS, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NABUMETONE TABLET [ALTURA PHARMACEUTICALS, INC.]2
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WONABUMETONE TABLET [ALTURA PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NABUMETONE TABLET [ALTURA PHARMACEUTICALS, INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ANABUMETONE TABLET [ALTURA PHARMACEUTICALS, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HNABUMETONE TABLET [ALTURA PHARMACEUTICALS, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNABUMETONE TABLET [ALTURA PHARMACEUTICALS, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2NABUMETONE TABLET [ALTURA PHARMACEUTICALS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNABUMETONE TABLET [ALTURA PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63874-687NABUMETONE TABLET [ALTURA PHARMACEUTICALS, INC.]2Legacy NDC, 4 package rows20100503_e66a5a08-7121-4987-bda1-7f3dbc5ed680.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311892nabumetone 500 MG Oral TabletPSNe66a5a08-7121-4987-bda1-7f3dbc5ed6802
311893nabumetone 750 MG Oral TabletPSNe66a5a08-7121-4987-bda1-7f3dbc5ed6802
311892nabumetone 500 MG Oral TabletSCDe66a5a08-7121-4987-bda1-7f3dbc5ed6802
311893nabumetone 750 MG Oral TabletSCDe66a5a08-7121-4987-bda1-7f3dbc5ed6802

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63874-687-0163874068701100 in 1 BOTTLE, PLASTICHistorical
63874-687-306387406873030 in 1 BOTTLE, PLASTICHistorical
63874-687-606387406876060 in 1 BOTTLE, PLASTICHistorical
63874-687-906387406879090 in 1 BOTTLE, PLASTICHistorical