hemlibra

Generic: emicizumab

Labeler: genentech, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name hemlibra
Generic Name emicizumab
Labeler genentech, inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

emicizumab 12 mg/.4mL

Manufacturer
Genentech, Inc.

Identifiers & Regulatory

Product NDC 50242-927
Product ID 50242-927_8f25ff10-e9d1-46a1-9889-e2c3f6e0d432
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761083
Listing Expiration 2026-12-31
Marketing Start 2024-01-31

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50242927
Hyphenated Format 50242-927

Supplemental Identifiers

RxCUI
1989799 1989804 1989809 1989811 1989814 1989815 1989816 1989817 2632728 2632729 2675567 2675568
UNII
7NL2E3F6K3

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name hemlibra (source: ndc)
Generic Name emicizumab (source: ndc)
Application Number BLA761083 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 12 mg/.4mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (50242-927-01) / .4 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

50242-927-01 1 VIAL, SINGLE-USE in 1 CARTON (50242-927-01) / .4 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

emicizumab (12 mg/.4mL)

Linked Drug Pages (1)

Hemlibra ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "8f25ff10-e9d1-46a1-9889-e2c3f6e0d432", "openfda": {"unii": ["7NL2E3F6K3"], "rxcui": ["1989799", "1989804", "1989809", "1989811", "1989814", "1989815", "1989816", "1989817", "2632728", "2632729", "2675567", "2675568"], "spl_set_id": ["2483adba-fab6-4d1b-96c5-c195577ed071"], "manufacturer_name": ["Genentech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (50242-927-01)  / .4 mL in 1 VIAL, SINGLE-USE", "package_ndc": "50242-927-01", "marketing_start_date": "20240131"}], "brand_name": "Hemlibra", "product_id": "50242-927_8f25ff10-e9d1-46a1-9889-e2c3f6e0d432", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "50242-927", "generic_name": "emicizumab", "labeler_name": "Genentech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hemlibra", "active_ingredients": [{"name": "EMICIZUMAB", "strength": "12 mg/.4mL"}], "application_number": "BLA761083", "marketing_category": "BLA", "marketing_start_date": "20240131", "listing_expiration_date": "20261231"}