FDA.reportPublic FDA data

Hemlibra

Product NDC
50242-922
11-digit product format
502420922
Labeler code
50242
Product ID
50242-922_8f25ff10-e9d1-46a1-9889-e2c3f6e0d432
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
emicizumab
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Genentech, Inc.
Application
BLA761083
Marketing category
BLA
Marketing start
2017-11-16
Substance
EMICIZUMAB
Active strength
105 mg/.7mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EMICIZUMAB105 mg/.7mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7NL2E3F6K3
Rxcui1989799, 1989804, 1989809, 1989811, 1989814, 1989815, 1989816, 1989817, 2632728, 2632729, 2675567, 2675568

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
681ccd64-d3b5-423c-847f-310cdc6d26cfProduct name120190117
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50242-922-01Hemlibra0.7 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION0.717
50242-922-01Hemlibra1 in 1 CARTONINJECTION, SOLUTION117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50242-922-01ML - Milliliter50242-92276e3b75e-ef9c-4234-8ca7-22ef513d925d12017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50242-922HEMLIBRA (EMICIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]16Current NDC, Legacy NDC, 2 package rows20241121_2483adba-fab6-4d1b-96c5-c195577ed071.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1989809emicizumab-kxwh 105 MG in 0.7 ML InjectionPSN2483adba-fab6-4d1b-96c5-c195577ed07117
2675567emicizumab-kxwh 12 MG in 0.4 ML InjectionPSN2483adba-fab6-4d1b-96c5-c195577ed07117
1989816emicizumab-kxwh 150 MG in 1 ML InjectionPSN2483adba-fab6-4d1b-96c5-c195577ed07117
1989799emicizumab-kxwh 30 MG in 1 ML InjectionPSN2483adba-fab6-4d1b-96c5-c195577ed07117
2632728emicizumab-kxwh 300 MG in 2 ML InjectionPSN2483adba-fab6-4d1b-96c5-c195577ed07117
1989814emicizumab-kxwh 60 MG in 0.4 ML InjectionPSN2483adba-fab6-4d1b-96c5-c195577ed07117
1989811Hemlibra 105 MG in 0.7 ML InjectionPSN2483adba-fab6-4d1b-96c5-c195577ed07117
2675568Hemlibra 12 MG in 0.4 ML InjectionPSN2483adba-fab6-4d1b-96c5-c195577ed07117
1989817Hemlibra 150 MG in 1 ML InjectionPSN2483adba-fab6-4d1b-96c5-c195577ed07117
1989804Hemlibra 30 MG in 1 ML InjectionPSN2483adba-fab6-4d1b-96c5-c195577ed07117
2632729Hemlibra 300 MG in 2 ML InjectionPSN2483adba-fab6-4d1b-96c5-c195577ed07117
1989815Hemlibra 60 MG in 0.4 ML InjectionPSN2483adba-fab6-4d1b-96c5-c195577ed07117
19898150.4 ML emicizumab-kxwh 150 MG/ML Injection [Hemlibra]SBD2483adba-fab6-4d1b-96c5-c195577ed07117
26755680.4 ML emicizumab-kxwh 30 MG/ML Injection [Hemlibra]SBD2483adba-fab6-4d1b-96c5-c195577ed07117
19898110.7 ML emicizumab-kxwh 150 MG/ML Injection [Hemlibra]SBD2483adba-fab6-4d1b-96c5-c195577ed07117
19898171 ML emicizumab-kxwh 150 MG/ML Injection [Hemlibra]SBD2483adba-fab6-4d1b-96c5-c195577ed07117
19898041 ML emicizumab-kxwh 30 MG/ML Injection [Hemlibra]SBD2483adba-fab6-4d1b-96c5-c195577ed07117
26327292 ML emicizumab-kxwh 150 MG/ML Injection [Hemlibra]SBD2483adba-fab6-4d1b-96c5-c195577ed07117
19898140.4 ML emicizumab-kxwh 150 MG/ML InjectionSCD2483adba-fab6-4d1b-96c5-c195577ed07117
26755670.4 ML emicizumab-kxwh 30 MG/ML InjectionSCD2483adba-fab6-4d1b-96c5-c195577ed07117
19898090.7 ML emicizumab-kxwh 150 MG/ML InjectionSCD2483adba-fab6-4d1b-96c5-c195577ed07117
19898161 ML emicizumab-kxwh 150 MG/ML InjectionSCD2483adba-fab6-4d1b-96c5-c195577ed07117
19897991 ML emicizumab-kxwh 30 MG/ML InjectionSCD2483adba-fab6-4d1b-96c5-c195577ed07117
26327282 ML emicizumab-kxwh 150 MG/ML InjectionSCD2483adba-fab6-4d1b-96c5-c195577ed07117
26755680.4 ML Hemlibra 30 MG/ML InjectionSY2483adba-fab6-4d1b-96c5-c195577ed07117
26327292 ML Hemlibra 150 MG/ML InjectionSY2483adba-fab6-4d1b-96c5-c195577ed07117
1989809emicizumab-kxwh 105 MG per 0.7 ML InjectionSY2483adba-fab6-4d1b-96c5-c195577ed07117
2675567emicizumab-kxwh 12 MG per 0.4 ML InjectionSY2483adba-fab6-4d1b-96c5-c195577ed07117
1989816emicizumab-kxwh 150 MG per 1 ML InjectionSY2483adba-fab6-4d1b-96c5-c195577ed07117
1989814emicizumab-kxwh 150 MG/ML per 0.4 ML InjectionSY2483adba-fab6-4d1b-96c5-c195577ed07117
1989809emicizumab-kxwh 150 MG/ML per 0.7 ML InjectionSY2483adba-fab6-4d1b-96c5-c195577ed07117
1989799emicizumab-kxwh 30 MG per 1 ML InjectionSY2483adba-fab6-4d1b-96c5-c195577ed07117
2632728emicizumab-kxwh 300 MG per 2 ML InjectionSY2483adba-fab6-4d1b-96c5-c195577ed07117
1989814emicizumab-kxwh 60 MG per 0.4 ML InjectionSY2483adba-fab6-4d1b-96c5-c195577ed07117
1989811Hemlibra 105 MG per 0.7 ML InjectionSY2483adba-fab6-4d1b-96c5-c195577ed07117
2675568Hemlibra 12 MG per 0.4 ML InjectionSY2483adba-fab6-4d1b-96c5-c195577ed07117
1989817Hemlibra 150 MG per 1 ML InjectionSY2483adba-fab6-4d1b-96c5-c195577ed07117
1989815Hemlibra 150 MG/ML per 0.4 ML InjectionSY2483adba-fab6-4d1b-96c5-c195577ed07117
1989811Hemlibra 150 MG/ML per 0.7 ML InjectionSY2483adba-fab6-4d1b-96c5-c195577ed07117
1989804Hemlibra 30 MG per 1 ML InjectionSY2483adba-fab6-4d1b-96c5-c195577ed07117
2632729Hemlibra 300 MG per 2 ML InjectionSY2483adba-fab6-4d1b-96c5-c195577ed07117
1989815Hemlibra 60 MG per 0.4 ML InjectionSY2483adba-fab6-4d1b-96c5-c195577ed07117

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50242-922-01502420922011 VIAL, SINGLE-USE in 1 CARTON (50242-922-01) / .7 mL in 1 VIAL, SINGLE-USE2017-11-160000-00-00NoNoCurrent