NDC 60574-4114

Synagis

Palivizumab

Synagis is a Intramuscular Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Medimmune, Llc. The primary component is Palivizumab.

• Product ID: 60574-4114_14cf114d-3f1e-485b-83f3-61d88c3c1a98
• NDC: 60574-4114
• Product Type: Human Prescription Drug
• Proprietary Name: Synagis
• Generic Name: Palivizumab
• Dosage Form: Injection, Solution
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 1999-12-09
• Marketing Category: BLA / BLA
• Application Number: BLA103770
• Labeler Name: MedImmune, LLC
• Substance Name: PALIVIZUMAB
• Active Ingredient Strength: 50 mg/.5mL
• Pharm Classes: Antibodies, Monoclonal [CS],Fusion Protein Inhibitors [MoA],Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 60574-4114-1

.5 mL in 1 VIAL, SINGLE-DOSE (60574-4114-1)

• Marketing Start Date: 2005-09-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 60574-4114-1 [60574411401]

Synagis INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103770
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2005-09-28

Drug Details

Active Ingredients

Ingredient	Strength
PALIVIZUMAB	50 mg/.5mL

OpenFDA Data

• SPL SET ID: 8e35c4c8-bf56-458f-a73c-8f5733829788
• Manufacturer:
  • MedImmune, LLC
• UNII:
  • DQ448MW7KS
• RxNorm Concept Unique ID - RxCUI:
  • 1657343
  • 1657341
  • 1657361
  • 1657362

Pharmacological Class

• Antibodies
• Monoclonal [CS]
• Fusion Protein Inhibitors [MoA]
• Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody [EPC]
• Antibodies
• Monoclonal [CS]
• Fusion Protein Inhibitors [MoA]
• Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody [EPC]

NDC Crossover Matching brand name "Synagis" or generic name "Palivizumab"

NDC	Brand Name	Generic Name
60574-4113	Synagis	palivizumab
60574-4114	Synagis	palivizumab
66658-230	Synagis	palivizumab
66658-231	Synagis	palivizumab