NDC 61755-008

LIBTAYO

Cemiplimab-rwlc

LIBTAYO is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Regeneron Pharmaceuticals, Inc.. The primary component is Cemiplimab.

• Product ID: 61755-008_4a332bfc-7d40-4811-b33e-6aebcbbcc28c
• NDC: 61755-008
• Product Type: Human Prescription Drug
• Proprietary Name: LIBTAYO
• Generic Name: Cemiplimab-rwlc
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2018-09-28
• Marketing Category: BLA / BLA
• Application Number: BLA761097
• Labeler Name: Regeneron Pharmaceuticals, Inc.
• Substance Name: CEMIPLIMAB
• Active Ingredient Strength: 50 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 61755-008-01

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

• Marketing Start Date: 2018-09-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61755-008-01 [61755000801]

LIBTAYO INJECTION

• Marketing Category: BLA
• Application Number: BLA761097
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-09-28

Drug Details

Active Ingredients

Ingredient	Strength
CEMIPLIMAB	50 mg/mL

OpenFDA Data

• SPL SET ID: 4347ae1f-d397-4f18-8b70-03897e1c054a
• Manufacturer:
  • Regeneron Pharmaceuticals, Inc.
• UNII:
  • 6QVL057INT
• RxNorm Concept Unique ID - RxCUI:
  • 2058835
  • 2058830