Package 61755-008-01

Brand: libtayo

Generic: cemiplimab-rwlc
NDC Package

Package Facts

Identity

Package NDC 61755-008-01
Digits Only 6175500801
Product NDC 61755-008
Description

1 VIAL, SINGLE-USE in 1 CARTON (61755-008-01) / 7 mL in 1 VIAL, SINGLE-USE

Marketing

Marketing Status
Marketed Since 2018-09-28
Brand libtayo
Generic cemiplimab-rwlc
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "1e241c47-2ccb-434e-95f5-d45aa9e1ecf3", "openfda": {"unii": ["6QVL057INT"], "rxcui": ["2058830", "2058835"], "spl_set_id": ["4347ae1f-d397-4f18-8b70-03897e1c054a"], "manufacturer_name": ["Regeneron Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (61755-008-01)  / 7 mL in 1 VIAL, SINGLE-USE", "package_ndc": "61755-008-01", "marketing_start_date": "20180928"}], "brand_name": "LIBTAYO", "product_id": "61755-008_1e241c47-2ccb-434e-95f5-d45aa9e1ecf3", "dosage_form": "INJECTION", "product_ndc": "61755-008", "generic_name": "cemiplimab-rwlc", "labeler_name": "Regeneron Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LIBTAYO", "active_ingredients": [{"name": "CEMIPLIMAB", "strength": "50 mg/mL"}], "application_number": "BLA761097", "marketing_category": "BLA", "marketing_start_date": "20180928", "listing_expiration_date": "20261231"}