FDA.reportPublic FDA data

KENGREAL

Product NDC
10122-620
11-digit product format
101220620
Labeler code
10122
Product ID
10122-620_8c5e6180-c346-48e7-818d-471089de4ee7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cangrelor
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Chiesi USA, Inc.
Application
NDA204958
Marketing category
NDA
Marketing start
2015-07-08
Substance
CANGRELOR
Active strength
50 mg/1
Pharmacologic classes
Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 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
KENGREAL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CANGRELOR50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6AQ1Y404U7
Rxcui1656056, 1656061

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
895e0342-af2d-4b1f-b5fa-dd6f1458a465Product name120150819

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10122-620-01KENGREAL1 in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,110
10122-620-10KENGREAL10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10122-620-01EA - Each10122-620f634868f-9de5-4edf-af8c-30dceeab49b412018-03-08
10122-620-10EA - Each10122-6206279fe4e-4789-43d2-a5f8-249278b6c46d12018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10122-620KENGREAL (CANGRELOR) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CHIESI USA, INC.]7Current NDC, Legacy NDC, 2 package rows20220928_88b434fa-8891-4fd5-9d86-7ea64667c08f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1656056cangrelor 50 MG InjectionPSN88b434fa-8891-4fd5-9d86-7ea64667c08f10
1656061Kengreal 50 MG InjectionPSN88b434fa-8891-4fd5-9d86-7ea64667c08f10
1656061cangrelor 50 MG Injection [Kengreal]SBD88b434fa-8891-4fd5-9d86-7ea64667c08f10
1656056cangrelor 50 MG InjectionSCD88b434fa-8891-4fd5-9d86-7ea64667c08f10
1656061Kengreal 50 MG InjectionSY88b434fa-8891-4fd5-9d86-7ea64667c08f10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10122-620-01101220620011 in 1 VIAL, SINGLE-USEHistorical
10122-620-101012206201010 VIAL, SINGLE-USE in 1 CARTON (10122-620-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (10122-620-01) 2015-07-080000-00-00NoNoCurrent