Package 10122-165-02

Brand: elfabrio

Generic: pegunigalsidase alfa
NDC Package

Package Facts

Identity

Package NDC 10122-165-02
Digits Only 1012216502
Product NDC 10122-165
Product ID 10122-165_ca12aa63-7344-4996-bfb4-d2289c245f4a
Description

1 VIAL, SINGLE-DOSE in 1 CARTON (10122-165-02) / 2.5 mL in 1 VIAL, SINGLE-DOSE

Marketing

Marketing Status
Marketed Since 2024-07-08
Brand elfabrio
Generic pegunigalsidase alfa
Sample Package No

Linked Drug Pages (1)

ELFABRIO ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "ca12aa63-7344-4996-bfb4-d2289c245f4a", "openfda": {"nui": ["M0000794", "N0000175822"], "unii": ["8M7V7Q6537"], "rxcui": ["2637456", "2637462", "2676759", "2676760"], "spl_set_id": ["6fb674bf-744e-431f-92ef-b2a5a66c8cf3"], "pharm_class_cs": ["alpha-Glucosidases [CS]"], "pharm_class_epc": ["Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme [EPC]"], "manufacturer_name": ["Chiesi USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (10122-165-02)  / 2.5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "10122-165-02", "marketing_start_date": "20240708"}], "brand_name": "ELFABRIO", "product_id": "10122-165_ca12aa63-7344-4996-bfb4-d2289c245f4a", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "product_ndc": "10122-165", "generic_name": "pegunigalsidase alfa", "labeler_name": "Chiesi USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ELFABRIO", "active_ingredients": [{"name": "PEGUNIGALSIDASE ALFA", "strength": "5 mg/2.5mL"}], "application_number": "BLA761161", "marketing_category": "BLA", "marketing_start_date": "20230523", "listing_expiration_date": "20261231"}