Daurismo

Product NDC
0069-1531
11-digit product format
000691531
Labeler code
0069
Product ID
0069-1531_e850e390-b32e-4382-a2c7-d480c41bd3a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glasdegib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA210656
Marketing category
NDA
Marketing start
2018-12-10
Substance
GLASDEGIB
Active strength
100 mg/1
Pharmacologic classes
Hedgehog Pathway Inhibitor [EPC], Smoothened Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLASDEGIB100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK673DMO5H9
Rxcui2105850, 2105856, 2105858, 2105860

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
eee4ef94-a1f8-40ae-b4d8-5566f596f1efProduct name120190313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-1531-30Daurismo30 in 1 BOTTLETABLET, FILM COATED3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-1531-30EA - Each0069-15316da28f74-75e0-4a1d-b65a-be88d800784d12018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-1531DAURISMO (GLASDEGIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]9Current NDC, Legacy NDC, 1 package rows20250121_204a6f7e-c9a4-472b-abd2-9527bda64d17.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2105856Daurismo 100 MG Oral TabletPSN204a6f7e-c9a4-472b-abd2-9527bda64d1711
2105860Daurismo 25 MG Oral TabletPSN204a6f7e-c9a4-472b-abd2-9527bda64d1711
2105850glasdegib 100 MG Oral TabletPSN204a6f7e-c9a4-472b-abd2-9527bda64d1711
2105858glasdegib 25 MG Oral TabletPSN204a6f7e-c9a4-472b-abd2-9527bda64d1711
2105856glasdegib 100 MG Oral Tablet [Daurismo]SBD204a6f7e-c9a4-472b-abd2-9527bda64d1711
2105860glasdegib 25 MG Oral Tablet [Daurismo]SBD204a6f7e-c9a4-472b-abd2-9527bda64d1711
2105850glasdegib 100 MG Oral TabletSCD204a6f7e-c9a4-472b-abd2-9527bda64d1711
2105858glasdegib 25 MG Oral TabletSCD204a6f7e-c9a4-472b-abd2-9527bda64d1711
2105856Daurismo 100 MG (as glasdegib maleate 131.1 MG) Oral TabletSY204a6f7e-c9a4-472b-abd2-9527bda64d1711
2105856Daurismo 100 MG Oral TabletSY204a6f7e-c9a4-472b-abd2-9527bda64d1711
2105860Daurismo 25 MG (as glasdegib maleate 32.8 MG) Oral TabletSY204a6f7e-c9a4-472b-abd2-9527bda64d1711
2105860Daurismo 25 MG Oral TabletSY204a6f7e-c9a4-472b-abd2-9527bda64d1711
2105850glasdegib 100 MG (as glasdegib maleate 131.1 MG) Oral TabletSY204a6f7e-c9a4-472b-abd2-9527bda64d1711
2105858glasdegib 25 MG (as glasdegib maleate 32.8 MG) Oral TabletSY204a6f7e-c9a4-472b-abd2-9527bda64d1711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0069-1531-300006915313030 TABLET, FILM COATED in 1 BOTTLE (0069-1531-30) 2018-12-100000-00-00NoNoCurrent