synagis

Generic: palivizumab

Labeler: swedish orphan biovitrum ab (publ)
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name synagis
Generic Name palivizumab
Labeler swedish orphan biovitrum ab (publ)
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

palivizumab 100 mg/mL

Manufacturer
Swedish Orphan Biovitrum AB (publ)

Identifiers & Regulatory

Product NDC 66658-231
Product ID 66658-231_48e6af70-cd93-3f1d-e063-6394a90a8104
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA103770
Marketing Start 1998-06-19
Marketing End 2026-07-31

Pharmacologic Class

Established (EPC)
respiratory syncytial virus anti-f protein monoclonal antibody [epc]
Mechanism of Action
fusion protein inhibitors [moa]
Chemical Structure
antibodies, monoclonal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66658231
Hyphenated Format 66658-231

Supplemental Identifiers

RxCUI
1657341 1657343 1657361 1657362
UPC
0366658231013
UNII
DQ448MW7KS
NUI
M0001357 N0000175615 N0000175623

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 synagis (source: ndc)
Generic Name palivizumab (source: ndc)
Application Number BLA103770 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 1 mL in 1 VIAL, SINGLE-DOSE (66658-231-01)
source: ndc

Packages (1)

66658-231-01 1 mL in 1 VIAL, SINGLE-DOSE (66658-231-01)

Ingredients (1)

palivizumab (100 mg/mL)

Linked Drug Pages (1)

Synagis ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "48e6af70-cd93-3f1d-e063-6394a90a8104", "openfda": {"nui": ["M0001357", "N0000175615", "N0000175623"], "upc": ["0366658231013"], "unii": ["DQ448MW7KS"], "rxcui": ["1657341", "1657343", "1657361", "1657362"], "spl_set_id": ["3a0096c7-8139-44cd-bba4-520ab05c2cb2"], "pharm_class_cs": ["Antibodies, Monoclonal [CS]"], "pharm_class_epc": ["Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody [EPC]"], "pharm_class_moa": ["Fusion Protein Inhibitors [MoA]"], "manufacturer_name": ["Swedish Orphan Biovitrum AB (publ)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 mL in 1 VIAL, SINGLE-DOSE (66658-231-01)", "package_ndc": "66658-231-01", "marketing_end_date": "20260731", "marketing_start_date": "20050928"}], "brand_name": "Synagis", "product_id": "66658-231_48e6af70-cd93-3f1d-e063-6394a90a8104", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antibodies", "Monoclonal [CS]", "Fusion Protein Inhibitors [MoA]", "Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody [EPC]"], "product_ndc": "66658-231", "generic_name": "palivizumab", "labeler_name": "Swedish Orphan Biovitrum AB (publ)", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Synagis", "active_ingredients": [{"name": "PALIVIZUMAB", "strength": "100 mg/mL"}], "application_number": "BLA103770", "marketing_category": "BLA", "marketing_end_date": "20260731", "marketing_start_date": "19980619"}