elfabrio

Generic: pegunigalsidase alfa

Labeler: chiesi usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name elfabrio
Generic Name pegunigalsidase alfa
Labeler chiesi usa, inc.
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

pegunigalsidase alfa 20 mg/10mL

Manufacturer
Chiesi USA, Inc.

Identifiers & Regulatory

Product NDC 10122-160
Product ID 10122-160_ca12aa63-7344-4996-bfb4-d2289c245f4a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761161
Listing Expiration 2026-12-31
Marketing Start 2023-05-23

Pharmacologic Class

Established (EPC)
hydrolytic lysosomal neutral glycosphingolipid-specific enzyme [epc]
Chemical Structure
alpha-glucosidases [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10122160
Hyphenated Format 10122-160

Supplemental Identifiers

RxCUI
2637456 2637462 2676759 2676760
UNII
8M7V7Q6537
NUI
M0000794 N0000175822

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 elfabrio (source: ndc)
Generic Name pegunigalsidase alfa (source: ndc)
Application Number BLA761161 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/10mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (10122-160-02) / 10 mL in 1 VIAL, SINGLE-DOSE (10122-160-01)
  • 5 VIAL, SINGLE-DOSE in 1 CARTON (10122-160-05) / 10 mL in 1 VIAL, SINGLE-DOSE (10122-160-01)
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (10122-160-10) / 10 mL in 1 VIAL, SINGLE-DOSE (10122-160-01)
source: ndc

Packages (3)

10122-160-02 1 VIAL, SINGLE-DOSE in 1 CARTON (10122-160-02) / 10 mL in 1 VIAL, SINGLE-DOSE (10122-160-01) 10122-160-05 5 VIAL, SINGLE-DOSE in 1 CARTON (10122-160-05) / 10 mL in 1 VIAL, SINGLE-DOSE (10122-160-01) 10122-160-10 10 VIAL, SINGLE-DOSE in 1 CARTON (10122-160-10) / 10 mL in 1 VIAL, SINGLE-DOSE (10122-160-01)

Ingredients (1)

pegunigalsidase alfa (20 mg/10mL)

Linked Drug Pages (1)

ELFABRIO ndc-match (0.9)

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 (10122-160-02)  / 10 mL in 1 VIAL, SINGLE-DOSE (10122-160-01)", "package_ndc": "10122-160-02", "marketing_start_date": "20230523"}, {"sample": false, "description": "5 VIAL, SINGLE-DOSE in 1 CARTON (10122-160-05)  / 10 mL in 1 VIAL, SINGLE-DOSE (10122-160-01)", "package_ndc": "10122-160-05", "marketing_start_date": "20230523"}, {"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (10122-160-10)  / 10 mL in 1 VIAL, SINGLE-DOSE (10122-160-01)", "package_ndc": "10122-160-10", "marketing_start_date": "20230523"}], "brand_name": "ELFABRIO", "product_id": "10122-160_ca12aa63-7344-4996-bfb4-d2289c245f4a", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "product_ndc": "10122-160", "generic_name": "pegunigalsidase alfa", "labeler_name": "Chiesi USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ELFABRIO", "active_ingredients": [{"name": "PEGUNIGALSIDASE ALFA", "strength": "20 mg/10mL"}], "application_number": "BLA761161", "marketing_category": "BLA", "marketing_start_date": "20230523", "listing_expiration_date": "20261231"}