FDA.reportPublic FDA data

SCEMBLIX

Product NDC
0078-1196
11-digit product format
000781196
Labeler code
0078
Product ID
0078-1196_e187165a-eb84-4ee5-98b8-d4e777ec7b4a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
asciminib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA215358
Marketing category
NDA
Marketing start
2021-10-29
Substance
ASCIMINIB HYDROCHLORIDE
Active strength
100 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
SCEMBLIX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASCIMINIB HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC5U34S9XFV
Rxcui2584320, 2584326, 2584328, 2584330, 2680278, 2680280

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f63ce078-abc5-4119-957d-2b977297ae12Product name120220524

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-1196-20SCEMBLIX60 in 1 BOTTLETABLET, FILM COATED6012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-1196-20EA - Each0078-11963a15b713-de8c-473a-9a06-62147def69de12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-1196SCEMBLIX (ASCIMINIB) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]9Current NDC, 1 package rows20241101_e33001e7-3650-42b1-ae56-cddb5c43aa2b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2680278asciminib 100 MG Oral TabletPSNe33001e7-3650-42b1-ae56-cddb5c43aa2b12
2584320asciminib 20 MG Oral TabletPSNe33001e7-3650-42b1-ae56-cddb5c43aa2b12
2584328asciminib 40 MG Oral TabletPSNe33001e7-3650-42b1-ae56-cddb5c43aa2b12
2680280SCEMBLIX 100 MG Oral TabletPSNe33001e7-3650-42b1-ae56-cddb5c43aa2b12
2584326SCEMBLIX 20 MG Oral TabletPSNe33001e7-3650-42b1-ae56-cddb5c43aa2b12
2584330SCEMBLIX 40 MG Oral TabletPSNe33001e7-3650-42b1-ae56-cddb5c43aa2b12
2680280asciminib 100 MG Oral Tablet [Scemblix]SBDe33001e7-3650-42b1-ae56-cddb5c43aa2b12
2584326asciminib 20 MG Oral Tablet [Scemblix]SBDe33001e7-3650-42b1-ae56-cddb5c43aa2b12
2584330asciminib 40 MG Oral Tablet [Scemblix]SBDe33001e7-3650-42b1-ae56-cddb5c43aa2b12
2680278asciminib 100 MG Oral TabletSCDe33001e7-3650-42b1-ae56-cddb5c43aa2b12
2584320asciminib 20 MG Oral TabletSCDe33001e7-3650-42b1-ae56-cddb5c43aa2b12
2584328asciminib 40 MG Oral TabletSCDe33001e7-3650-42b1-ae56-cddb5c43aa2b12
2680278asciminib 100 MG (equivalent to asciminib HCl 108.10 MG) Oral TabletSYe33001e7-3650-42b1-ae56-cddb5c43aa2b12
2584320asciminib 20 MG (equivalent to asciminib HCl 21.62 MG) Oral TabletSYe33001e7-3650-42b1-ae56-cddb5c43aa2b12
2584328asciminib 40 MG (equivalent to asciminib HCl 43.24 MG) Oral TabletSYe33001e7-3650-42b1-ae56-cddb5c43aa2b12
2680280Scemblix 100 MG (equivalent to asciminib HCl 108.10 MG) Oral TabletSYe33001e7-3650-42b1-ae56-cddb5c43aa2b12
2680280Scemblix 100 MG Oral TabletSYe33001e7-3650-42b1-ae56-cddb5c43aa2b12
2584326Scemblix 20 MG (equivalent to asciminib HCl 21.62 MG) Oral TabletSYe33001e7-3650-42b1-ae56-cddb5c43aa2b12
2584326Scemblix 20 MG Oral TabletSYe33001e7-3650-42b1-ae56-cddb5c43aa2b12
2584330Scemblix 40 MG (equivalent to asciminib HCl 43.24 MG) Oral TabletSYe33001e7-3650-42b1-ae56-cddb5c43aa2b12
2584330Scemblix 40 MG Oral TabletSYe33001e7-3650-42b1-ae56-cddb5c43aa2b12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0078-1196-200007811962060 TABLET, FILM COATED in 1 BOTTLE (0078-1196-20) 2024-04-18NoNoHistorical