NDC 0003-2328

YERVOY

Ipilimumab

YERVOY is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by E.r. Squibb & Sons, L.l.c.. The primary component is Ipilimumab.

• Product ID: 0003-2328_18f077d2-f5e7-422b-86be-0640c317b8ed
• NDC: 0003-2328
• Product Type: Human Prescription Drug
• Proprietary Name: YERVOY
• Generic Name: Ipilimumab
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2011-03-25
• Marketing Category: BLA / BLA
• Application Number: BLA125377
• Labeler Name: E.R. Squibb & Sons, L.L.C.
• Substance Name: IPILIMUMAB
• Active Ingredient Strength: 5 mg/mL
• Pharm Classes: CTLA-4-directed Blocking Antibody [EPC],CTLA-4-directed Antibody Interactions [MoA],Increased T Lymphocyte Activation [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0003-2328-22

1 VIAL, SINGLE-USE in 1 CARTON (0003-2328-22) > 40 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2011-03-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0003-2328-22 [00003232822]

YERVOY INJECTION

• Marketing Category: BLA
• Application Number: BLA125377
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2011-03-25

Drug Details

Active Ingredients

Ingredient	Strength
IPILIMUMAB	5 mg/mL

OpenFDA Data

• SPL SET ID: 2265ef30-253e-11df-8a39-0800200c9a66
• Manufacturer:
  • E.R. Squibb & Sons, L.L.C.
• UNII:
  • 6T8C155666
• RxNorm Concept Unique ID - RxCUI:
  • 1657005
  • 1657007
  • 1657013
  • 1657012

Pharmacological Class

• CTLA-4-directed Blocking Antibody [EPC]
• CTLA-4-directed Antibody Interactions [MoA]
• Increased T Lymphocyte Activation [PE]

NDC Crossover Matching brand name "YERVOY" or generic name "Ipilimumab"

NDC	Brand Name	Generic Name
0003-2327	YERVOY	ipilimumab
0003-2328	YERVOY	ipilimumab