libtayo

Generic: cemiplimab-rwlc

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

Drug Facts

Product Profile

Brand Name libtayo
Generic Name cemiplimab-rwlc
Labeler regeneron pharmaceuticals, inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

cemiplimab 50 mg/mL

Manufacturer
Regeneron Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 61755-008
Product ID 61755-008_1e241c47-2ccb-434e-95f5-d45aa9e1ecf3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761097
Listing Expiration 2026-12-31
Marketing Start 2018-09-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61755008
Hyphenated Format 61755-008

Supplemental Identifiers

RxCUI
2058830 2058835
UNII
6QVL057INT

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 libtayo (source: ndc)
Generic Name cemiplimab-rwlc (source: ndc)
Application Number BLA761097 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (61755-008-01) / 7 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

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

Ingredients (1)

cemiplimab (50 mg/mL)

Linked Drug Pages (1)

LIBTAYO ndc-match (0.9)

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"}