NDC 0003-3774

OPDIVO

Nivolumab

OPDIVO 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 Nivolumab.

• Product ID: 0003-3774_01929db8-1a98-404e-b4dd-0664e6c0c212
• NDC: 0003-3774
• Product Type: Human Prescription Drug
• Proprietary Name: OPDIVO
• Generic Name: Nivolumab
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2014-12-22
• Marketing Category: BLA / BLA
• Application Number: BLA125554
• Labeler Name: E.R. Squibb & Sons, L.L.C.
• Substance Name: NIVOLUMAB
• Active Ingredient Strength: 10 mg/mL
• Pharm Classes: Programmed Death Receptor-1 Blocking Antibody [EPC],Programmed Death Receptor-1-directed Antibody Interactions [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0003-3774-12

1 VIAL, SINGLE-DOSE in 1 CARTON (0003-3774-12) > 10 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2014-12-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0003-3774-12 [00003377412]

OPDIVO INJECTION

• Marketing Category: BLA
• Application Number: BLA125554
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-12-22

Drug Details

Active Ingredients

Ingredient	Strength
NIVOLUMAB	10 mg/mL

OpenFDA Data

• SPL SET ID: f570b9c4-6846-4de2-abfa-4d0a4ae4e394
• Manufacturer:
  • E.R. Squibb & Sons, L.L.C.
• UNII:
  • 31YO63LBSN
• RxNorm Concept Unique ID - RxCUI:
  • 1657192
  • 1657190
  • 1657196
  • 1657195
  • 1991412
  • 1991413

Pharmacological Class

• Programmed Death Receptor-1 Blocking Antibody [EPC]
• Programmed Death Receptor-1-directed Antibody Interactions [MoA]

NDC Crossover Matching brand name "OPDIVO" or generic name "Nivolumab"

NDC	Brand Name	Generic Name
0003-3734	OPDIVO	nivolumab
0003-3756	OPDIVO	nivolumab
0003-3772	OPDIVO	nivolumab
0003-3774	OPDIVO	OPDIVO