FDA.reportPublic FDA data

Alhemo

Product NDC
0169-2080
11-digit product format
001692080
Labeler code
0169
Product ID
0169-2080_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
100 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
CONCIZUMAB100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
68603V9EAFInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2708346Internal RxNorm lookup
2708353Internal RxNorm lookup
2708356Internal RxNorm lookup
2708359Internal RxNorm lookup
2708361Internal RxNorm lookup
2708362Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
156f6404-1f6f-417f-bcf8-f07a27a82cc1Available on FDA.report

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
0169-2080-15Alhemo1 in 1 CARTONINJECTION, SOLUTION16
0169-2080-15Alhemo1.5 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION1.56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0169-2080-15ML - Milliliter0169-20806c92cf19-22b3-46b3-9b74-a0380421d88412025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0169-2080ALHEMO (CONCIZUMAB) INJECTION, SOLUTION [NOVO NORDISK]5Current NDC, 2 package rows20250516_156f6404-1f6f-417f-bcf8-f07a27a82cc1.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlhemoCONCIZUMABNovo Nordisk156f6404-1f6f-417f-bcf8-f07a27a82cc12025-07-01Warnings, Adverse reactionsExact identifier
application number: BLA761315
ndc (product): 0169-2080

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761315Alhemoconcizumab-mtci351(a)Rx2026-07-01

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
0169-2080-15001692080151 SYRINGE, PLASTIC in 1 CARTON (0169-2080-15) / 1.5 mL in 1 SYRINGE, PLASTIC2025-02-19NoNoCurrent