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NDC 50242-0922-01 Hemlibra 105 mg/.7mL Details

Hemlibra 105 mg/.7mL

Hemlibra is a SUBCUTANEOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Genentech, Inc.. The primary component is EMICIZUMAB.

MedlinePlus Drug Summary

Emicizumab-kxwh injection is used to prevent or reduce the frequency of bleeding in adults, children, and infants with hemophilia A (condition in which the blood does not clot normally because of a missing or faulty blood clotting factor). Emicizumab-kxwh is in a class of medications called hemostatic antibodies. It works by acting as a bridge between clotting factors to help your blood clot.

Related Packages: 50242-0922-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Emicizumab-kxwh Injection

Product Information

NDC	50242-0922
Product ID	50242-922_bbf98231-9308-4099-9808-a170a48fdfb3
Associated GPIs	85105030202030
GCN Sequence Number	077936
GCN Sequence Number Description	emicizumab-kxwh VIAL 105 MG/0.7 SUBCUT
HIC3	M0P
HIC3 Description	HEMOPHILIA TREATMENT AGENTS,NON-FACTOR REPLACEMENT
GCN	44106
HICL Sequence Number	044640
HICL Sequence Number Description	EMICIZUMAB-KXWH
Brand/Generic	Brand
Proprietary Name	Hemlibra
Proprietary Name Suffix	n/a
Non-Proprietary Name	emicizumab
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	INJECTION, SOLUTION
Route	SUBCUTANEOUS
Active Ingredient Strength	105
Active Ingredient Units	mg/.7mL
Substance Name	EMICIZUMAB
Labeler Name	Genentech, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	BLA
Application Number	BLA761083
Listing Certified Through	2024-12-31

Package

NDC 50242-0922-01 (50242092201)

Pricing Information	N/A
NDC Package Code	50242-922-01
Billing NDC	50242092201
Package	1 VIAL, SINGLE-USE in 1 CARTON (50242-922-01) / .7 mL in 1 VIAL, SINGLE-USE
Marketing Start Date	2017-11-16
NDC Exclude Flag	N