FDA.reportPublic FDA data

Alhemo

Product NDC
0169-2084
11-digit product format
001692084
Labeler code
0169
Product ID
0169-2084_ff2589ac-650f-4740-984d-e950f785c1fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
concizumab
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Novo Nordisk
Application
BLA761315
Marketing category
BLA
Marketing start
2025-02-19
Substance
CONCIZUMAB
Active strength
40 mg/mL
Pharmacologic classes
Tissue Factor Pathway Inhibitor Antagonist [EPC], Tissue Factor Pathway Inhibitor 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
Alhemo
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CONCIZUMAB40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii68603V9EAF
Rxcui2708346, 2708353, 2708356, 2708359, 2708361, 2708362

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c51313be-0b8c-417f-ba9f-7c23c446829aProduct name120251021
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0169-2084-15Alhemo1.5 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION1.56
0169-2084-15Alhemo1 in 1 CARTONINJECTION, SOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0169-2084-15ML - Milliliter0169-2084ed568662-c28a-4e16-b043-88e662fb78eb12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0169-2084ALHEMO (CONCIZUMAB) INJECTION, SOLUTION [NOVO NORDISK]5Current NDC, 2 package rows20250516_156f6404-1f6f-417f-bcf8-f07a27a82cc1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2708359Alhemo 150 MG in 1.5 ML Pen InjectorPSN156f6404-1f6f-417f-bcf8-f07a27a82cc16
2708362Alhemo 300 MG in 3 ML Pen InjectorPSN156f6404-1f6f-417f-bcf8-f07a27a82cc16
2708353Alhemo 60 MG in 1.5 ML Pen InjectorPSN156f6404-1f6f-417f-bcf8-f07a27a82cc16
2708356concizumab-mtci 150 MG in 1.5 ML Pen InjectorPSN156f6404-1f6f-417f-bcf8-f07a27a82cc16
2708361concizumab-mtci 300 MG in 3 ML Pen InjectorPSN156f6404-1f6f-417f-bcf8-f07a27a82cc16
2708346concizumab-mtci 60 MG in 1.5 ML Pen InjectorPSN156f6404-1f6f-417f-bcf8-f07a27a82cc16
27083591.5 ML concizumab-mtci 100 MG/ML Pen Injector [Alhemo]SBD156f6404-1f6f-417f-bcf8-f07a27a82cc16
27083531.5 ML concizumab-mtci 40 MG/ML Pen Injector [Alhemo]SBD156f6404-1f6f-417f-bcf8-f07a27a82cc16
27083623 ML concizumab-mtci 100 MG/ML Pen Injector [Alhemo]SBD156f6404-1f6f-417f-bcf8-f07a27a82cc16
27083561.5 ML concizumab-mtci 100 MG/ML Pen InjectorSCD156f6404-1f6f-417f-bcf8-f07a27a82cc16
27083461.5 ML concizumab-mtci 40 MG/ML Pen InjectorSCD156f6404-1f6f-417f-bcf8-f07a27a82cc16
27083613 ML concizumab-mtci 100 MG/ML Pen InjectorSCD156f6404-1f6f-417f-bcf8-f07a27a82cc16
27083591.5 ML Alhemo 100 MG/ML Pen InjectorSY156f6404-1f6f-417f-bcf8-f07a27a82cc16
27083531.5 ML Alhemo 40 MG/ML Pen InjectorSY156f6404-1f6f-417f-bcf8-f07a27a82cc16
27083623 ML Alhemo 100 MG/ML Pen InjectorSY156f6404-1f6f-417f-bcf8-f07a27a82cc16
2708359Alhemo 150 MG per 1.5 ML Pen InjectorSY156f6404-1f6f-417f-bcf8-f07a27a82cc16
2708362Alhemo 300 MG per 3 ML Pen InjectorSY156f6404-1f6f-417f-bcf8-f07a27a82cc16
2708353Alhemo 60 MG per 1.5 ML Pen InjectorSY156f6404-1f6f-417f-bcf8-f07a27a82cc16
2708356concizumab-mtci 150 MG per 1.5 ML Pen InjectorSY156f6404-1f6f-417f-bcf8-f07a27a82cc16
2708361concizumab-mtci 300 MG per 3 ML Pen InjectorSY156f6404-1f6f-417f-bcf8-f07a27a82cc16
2708346concizumab-mtci 60 MG per 1.5 ML Pen InjectorSY156f6404-1f6f-417f-bcf8-f07a27a82cc16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0169-2084-15001692084151 SYRINGE, PLASTIC in 1 CARTON (0169-2084-15) / 1.5 mL in 1 SYRINGE, PLASTIC2025-02-19NoNoCurrent