FDA.reportPublic FDA data

Mulpleta

Product NDC
59630-551
11-digit product format
596300551
Labeler code
59630
Product ID
59630-551_b520c88c-9064-4ffe-b33c-81fdfe795cad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lusutrombopag
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
SHIONOGI INC.
Application
NDA210923
Marketing category
NDA
Marketing start
2018-08-27
Substance
LUSUTROMBOPAG
Active strength
3 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mulpleta
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LUSUTROMBOPAG3 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6LL5JFU42F
Rxcui2054989, 2054995

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
bf82b36f-3fb0-49c2-b359-79c91ec8a6e9Product name120181011
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59630-551-07Mulpleta7 in 1 DOSE PACKTABLET, FILM COATED77
59630-551-07Mulpleta1 in 1 CARTONTABLET, FILM COATED17
59630-551-77Mulpleta1 in 1 CARTONTABLET, FILM COATED17
59630-551-77Mulpleta7 in 1 DOSE PACKTABLET, FILM COATED77

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59630-551-07EA - Each59630-5518d0ae06c-b3fb-4d7d-bf3e-fb71f68c642a12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59630-551MULPLETA (LUSUTROMBOPAG) TABLET, FILM COATED [SHIONOGI INC.]7Current NDC, Legacy NDC, 4 package rows20201031_f9fd0cfd-717d-4a87-99bc-de7b38807e55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2054989lusutrombopag 3 MG Oral TabletPSNf9fd0cfd-717d-4a87-99bc-de7b38807e557
2054995MULPLETA 3 MG Oral TabletPSNf9fd0cfd-717d-4a87-99bc-de7b38807e557
2054995lusutrombopag 3 MG Oral Tablet [Mulpleta]SBDf9fd0cfd-717d-4a87-99bc-de7b38807e557
2054989lusutrombopag 3 MG Oral TabletSCDf9fd0cfd-717d-4a87-99bc-de7b38807e557
2054995Mulpleta 3 MG Oral TabletSYf9fd0cfd-717d-4a87-99bc-de7b38807e557

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59630-551-07596300551071 DOSE PACK in 1 CARTON (59630-551-07) / 7 TABLET, FILM COATED in 1 DOSE PACK1 dose pack2018-08-270000-00-00NoNoCurrent
59630-551-77596300551771 DOSE PACK in 1 CARTON (59630-551-77) / 7 TABLET, FILM COATED in 1 DOSE PACK1 dose pack2018-08-270000-00-00YesNoCurrent