enflonsia

Generic: clesrovimab

Labeler: merck sharp & dohme llc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name enflonsia
Generic Name clesrovimab
Labeler merck sharp & dohme llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

clesrovimab 150 mg/mL

Manufacturer
Merck Sharp & Dohme LLC

Identifiers & Regulatory

Product NDC 0006-5073
Product ID 0006-5073_3db80030-7b81-4686-872e-bd202c44ff24
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761432
Listing Expiration 2026-12-31
Marketing Start 2025-06-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00065073
Hyphenated Format 0006-5073

Supplemental Identifiers

RxCUI
2716809 2716816
UNII
VJO29R4CP9
NUI
N0000175623 N0000175615

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 enflonsia (source: ndc)
Generic Name clesrovimab (source: ndc)
Application Number BLA761432 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 150 mg/mL
source: ndc
Packaging
  • 1 SYRINGE, GLASS in 1 CARTON (0006-5073-01) / .7 mL in 1 SYRINGE, GLASS (0006-5073-99)
  • 10 SYRINGE, GLASS in 1 CARTON (0006-5073-02) / .7 mL in 1 SYRINGE, GLASS (0006-5073-99)
source: ndc

Packages (2)

0006-5073-01 1 SYRINGE, GLASS in 1 CARTON (0006-5073-01) / .7 mL in 1 SYRINGE, GLASS (0006-5073-99) 0006-5073-02 10 SYRINGE, GLASS in 1 CARTON (0006-5073-02) / .7 mL in 1 SYRINGE, GLASS (0006-5073-99)

Ingredients (1)

clesrovimab (150 mg/mL)

Linked Drug Pages (1)

ENFLONSIA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "3db80030-7b81-4686-872e-bd202c44ff24", "openfda": {"nui": ["N0000175623", "N0000175615"], "unii": ["VJO29R4CP9"], "rxcui": ["2716809", "2716816"], "spl_set_id": ["c9004a92-40e8-4cdb-b22d-d07929f8fc3b"], "pharm_class_epc": ["Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody [EPC]"], "pharm_class_moa": ["Fusion Protein Inhibitors [MoA]"], "manufacturer_name": ["Merck Sharp & Dohme LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, GLASS in 1 CARTON (0006-5073-01)  / .7 mL in 1 SYRINGE, GLASS (0006-5073-99)", "package_ndc": "0006-5073-01", "marketing_start_date": "20250609"}, {"sample": false, "description": "10 SYRINGE, GLASS in 1 CARTON (0006-5073-02)  / .7 mL in 1 SYRINGE, GLASS (0006-5073-99)", "package_ndc": "0006-5073-02", "marketing_start_date": "20250609"}], "brand_name": "ENFLONSIA", "product_id": "0006-5073_3db80030-7b81-4686-872e-bd202c44ff24", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "0006-5073", "generic_name": "CLESROVIMAB", "labeler_name": "Merck Sharp & Dohme LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ENFLONSIA", "active_ingredients": [{"name": "CLESROVIMAB", "strength": "150 mg/mL"}], "application_number": "BLA761432", "marketing_category": "BLA", "marketing_start_date": "20250609", "listing_expiration_date": "20261231"}