Hemlibra

Product NDC: 50242-921
11-digit product format: 502420921
Labeler code: 50242
Product ID: 50242-921_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: 60 mg/.4mL
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
Ingredient	Strength
EMICIZUMAB	60 mg/.4mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7NL2E3F6K3	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1989799	Internal RxNorm lookup
1989804	Internal RxNorm lookup
1989809	Internal RxNorm lookup
1989811	Internal RxNorm lookup
1989814	Internal RxNorm lookup
1989815	Internal RxNorm lookup
1989816	Internal RxNorm lookup
1989817	Internal RxNorm lookup
2632728	Internal RxNorm lookup
2632729	Internal RxNorm lookup
2675567	Internal RxNorm lookup
2675568	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
2483adba-fab6-4d1b-96c5-c195577ed071	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
681ccd64-d3b5-423c-847f-310cdc6d26cf	Product name	1	20190117
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50242-921-01	Hemlibra	0.4 mL in 1 VIAL, SINGLE-USE	INJECTION, SOLUTION	0.4		17
50242-921-01	Hemlibra	1 in 1 CARTON	INJECTION, SOLUTION	1		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50242-921-01	ML - Milliliter	50242-921	598e7beb-a3f5-4589-8e33-933ae95fbb37	1	2017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50242-921	HEMLIBRA (EMICIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]	16	Current NDC, Legacy NDC, 2 package rows	20241121_2483adba-fab6-4d1b-96c5-c195577ed071.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hemlibra	EMICIZUMAB	Genentech, Inc.	2483adba-fab6-4d1b-96c5-c195577ed071	2025-07-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA761083 ndc (product): 50242-921

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761083	Hemlibra	emicizumab-kxwh	351(a)	Rx	2026-07-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7NL2E3F6K3	EMICIZUMAB	1610943-06-0	EMICIZUMAB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1989809	emicizumab-kxwh 105 MG in 0.7 ML Injection	PSN	2483adba-fab6-4d1b-96c5-c195577ed071	17
2675567	emicizumab-kxwh 12 MG in 0.4 ML Injection	PSN	2483adba-fab6-4d1b-96c5-c195577ed071	17
1989816	emicizumab-kxwh 150 MG in 1 ML Injection	PSN	2483adba-fab6-4d1b-96c5-c195577ed071	17
1989799	emicizumab-kxwh 30 MG in 1 ML Injection	PSN	2483adba-fab6-4d1b-96c5-c195577ed071	17
2632728	emicizumab-kxwh 300 MG in 2 ML Injection	PSN	2483adba-fab6-4d1b-96c5-c195577ed071	17
1989814	emicizumab-kxwh 60 MG in 0.4 ML Injection	PSN	2483adba-fab6-4d1b-96c5-c195577ed071	17
1989811	Hemlibra 105 MG in 0.7 ML Injection	PSN	2483adba-fab6-4d1b-96c5-c195577ed071	17
2675568	Hemlibra 12 MG in 0.4 ML Injection	PSN	2483adba-fab6-4d1b-96c5-c195577ed071	17
1989817	Hemlibra 150 MG in 1 ML Injection	PSN	2483adba-fab6-4d1b-96c5-c195577ed071	17
1989804	Hemlibra 30 MG in 1 ML Injection	PSN	2483adba-fab6-4d1b-96c5-c195577ed071	17
2632729	Hemlibra 300 MG in 2 ML Injection	PSN	2483adba-fab6-4d1b-96c5-c195577ed071	17
1989815	Hemlibra 60 MG in 0.4 ML Injection	PSN	2483adba-fab6-4d1b-96c5-c195577ed071	17
1989815	0.4 ML emicizumab-kxwh 150 MG/ML Injection [Hemlibra]	SBD	2483adba-fab6-4d1b-96c5-c195577ed071	17
2675568	0.4 ML emicizumab-kxwh 30 MG/ML Injection [Hemlibra]	SBD	2483adba-fab6-4d1b-96c5-c195577ed071	17
1989811	0.7 ML emicizumab-kxwh 150 MG/ML Injection [Hemlibra]	SBD	2483adba-fab6-4d1b-96c5-c195577ed071	17
1989817	1 ML emicizumab-kxwh 150 MG/ML Injection [Hemlibra]	SBD	2483adba-fab6-4d1b-96c5-c195577ed071	17
1989804	1 ML emicizumab-kxwh 30 MG/ML Injection [Hemlibra]	SBD	2483adba-fab6-4d1b-96c5-c195577ed071	17
2632729	2 ML emicizumab-kxwh 150 MG/ML Injection [Hemlibra]	SBD	2483adba-fab6-4d1b-96c5-c195577ed071	17
1989814	0.4 ML emicizumab-kxwh 150 MG/ML Injection	SCD	2483adba-fab6-4d1b-96c5-c195577ed071	17
2675567	0.4 ML emicizumab-kxwh 30 MG/ML Injection	SCD	2483adba-fab6-4d1b-96c5-c195577ed071	17
1989809	0.7 ML emicizumab-kxwh 150 MG/ML Injection	SCD	2483adba-fab6-4d1b-96c5-c195577ed071	17
1989816	1 ML emicizumab-kxwh 150 MG/ML Injection	SCD	2483adba-fab6-4d1b-96c5-c195577ed071	17
1989799	1 ML emicizumab-kxwh 30 MG/ML Injection	SCD	2483adba-fab6-4d1b-96c5-c195577ed071	17
2632728	2 ML emicizumab-kxwh 150 MG/ML Injection	SCD	2483adba-fab6-4d1b-96c5-c195577ed071	17
2675568	0.4 ML Hemlibra 30 MG/ML Injection	SY	2483adba-fab6-4d1b-96c5-c195577ed071	17
2632729	2 ML Hemlibra 150 MG/ML Injection	SY	2483adba-fab6-4d1b-96c5-c195577ed071	17
1989809	emicizumab-kxwh 105 MG per 0.7 ML Injection	SY	2483adba-fab6-4d1b-96c5-c195577ed071	17
2675567	emicizumab-kxwh 12 MG per 0.4 ML Injection	SY	2483adba-fab6-4d1b-96c5-c195577ed071	17
1989816	emicizumab-kxwh 150 MG per 1 ML Injection	SY	2483adba-fab6-4d1b-96c5-c195577ed071	17
1989814	emicizumab-kxwh 150 MG/ML per 0.4 ML Injection	SY	2483adba-fab6-4d1b-96c5-c195577ed071	17
1989809	emicizumab-kxwh 150 MG/ML per 0.7 ML Injection	SY	2483adba-fab6-4d1b-96c5-c195577ed071	17
1989799	emicizumab-kxwh 30 MG per 1 ML Injection	SY	2483adba-fab6-4d1b-96c5-c195577ed071	17
2632728	emicizumab-kxwh 300 MG per 2 ML Injection	SY	2483adba-fab6-4d1b-96c5-c195577ed071	17
1989814	emicizumab-kxwh 60 MG per 0.4 ML Injection	SY	2483adba-fab6-4d1b-96c5-c195577ed071	17
1989811	Hemlibra 105 MG per 0.7 ML Injection	SY	2483adba-fab6-4d1b-96c5-c195577ed071	17
2675568	Hemlibra 12 MG per 0.4 ML Injection	SY	2483adba-fab6-4d1b-96c5-c195577ed071	17
1989817	Hemlibra 150 MG per 1 ML Injection	SY	2483adba-fab6-4d1b-96c5-c195577ed071	17
1989815	Hemlibra 150 MG/ML per 0.4 ML Injection	SY	2483adba-fab6-4d1b-96c5-c195577ed071	17
1989811	Hemlibra 150 MG/ML per 0.7 ML Injection	SY	2483adba-fab6-4d1b-96c5-c195577ed071	17
1989804	Hemlibra 30 MG per 1 ML Injection	SY	2483adba-fab6-4d1b-96c5-c195577ed071	17
2632729	Hemlibra 300 MG per 2 ML Injection	SY	2483adba-fab6-4d1b-96c5-c195577ed071	17
1989815	Hemlibra 60 MG per 0.4 ML Injection	SY	2483adba-fab6-4d1b-96c5-c195577ed071	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50242-921-01	50242092101	1 VIAL, SINGLE-USE in 1 CARTON (50242-921-01) / .4 mL in 1 VIAL, SINGLE-USE	2017-11-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hemlibra	Genentech, Inc. \| F. Hoffmann-La Roche Ltd. \| Roche Diagnostics \| F. Hoffmann-La Roche AG	2025-07-11	HUMAN PRESCRIPTION DRUG LABEL	17