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NDC 10122-0160-02 ELFABRIO 20 mg/10mL Details
ELFABRIO 20 mg/10mL
ELFABRIO is a INTRAVENOUS INJECTION, SOLUTION, CONCENTRATE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Chiesi USA, Inc.. The primary component is PEGUNIGALSIDASE ALFA.
MedlinePlus Drug Summary
Pegunigalsidase alfa-iwxj injection is used to treat Fabry disease (an inherited condition in which a type of fatty substance builds up in the body, resulting in nerve and organ damage). Pegunigalsidase alfa-iwxj injection is in a class of medications called enzymes. It works by replacing an enzyme that is normally produced by the body that helps prevents the build of the fatty substance in the body.
Related Packages: 10122-0160-02Last Updated: 03/24/2024
MedLinePlus Full Drug Details: Pegunigalsidase alfa-iwxj Injection
Product Information
| NDC | 10122-0160 |
|---|---|
| Product ID | 10122-160_87c2b108-9c81-4ddb-83d1-d61f88783c37 |
| Associated GPIs | |
| GCN Sequence Number | 084769 |
| GCN Sequence Number Description | pegunigalsidase alfa-iwxj VIAL 20 MG/10ML INTRAVEN |
| HIC3 | Z1H |
| HIC3 Description | METABOLIC DISEASE ENZYME REPLACEMENT, FABRY'S DX |
| GCN | 54146 |
| HICL Sequence Number | 048913 |
| HICL Sequence Number Description | PEGUNIGALSIDASE ALFA-IWXJ |
| Brand/Generic | Brand |
| Proprietary Name | ELFABRIO |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | pegunigalsidase alfa |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION, CONCENTRATE |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 20 |
| Active Ingredient Units | mg/10mL |
| Substance Name | PEGUNIGALSIDASE ALFA |
| Labeler Name | Chiesi USA, Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA761161 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 10122-0160-02 (10122016002)
| NDC Package Code | 10122-160-02 |
|---|---|
| Billing NDC | 10122016002 |
| Package | 1 VIAL, SINGLE-DOSE in 1 CARTON (10122-160-02) / 10 mL in 1 VIAL, SINGLE-DOSE (10122-160-01) |
| Marketing Start Date | 2023-05-23 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |