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United States · US · US:10122-160_ca12aa63-7344-4996-bfb4-d2289c245f4a
ELFABRIO
UNIISPLATC A16AB20
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerChiesi USA, Inc.
CountryUS (United States)
ATC codeA16AB20
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1110122160021 VIAL, SINGLE-DOSE in 1 CARTON (10122-160-02) / 10 mL in 1 VIAL, SINGLE-DOSE (10122-160-01)
- ndc1110122160055 VIAL, SINGLE-DOSE in 1 CARTON (10122-160-05) / 10 mL in 1 VIAL, SINGLE-DOSE (10122-160-01)
- ndc11101221601010 VIAL, SINGLE-DOSE in 1 CARTON (10122-160-10) / 10 mL in 1 VIAL, SINGLE-DOSE (10122-160-01)
Annotations
UNII (FDA Substance ID)
8M7V7Q6537
PEGUNIGALSIDASE ALFA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "8M7V7Q6537",
"rxcui": null,
"inchikey": null,
"display_name": "PEGUNIGALSIDASE ALFA",
"substance_type": "protein",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"6fb674bf-744e-431f-92ef-b2a5a66c8cf3": {
"match": "brand_token",
"title": "ELFABRIO (PEGUNIGALSIDASE ALFA) INJECTION, SOLUTION, CONCENTRATE [CHIESI USA, INC.]",
"spl_version": "7",
"published_date": "2024-07-09"
}
},
"productid": "10122-160_ca12aa63-7344-4996-bfb4-d2289c245f4a",
"productndc": "10122-160",
"dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PEGUNIGALSIDASE ALFA",
"proprietary_name": "ELFABRIO",
"active_ingred_unit": "mg/10mL",
"application_number": "BLA761161",
"marketing_category": "BLA",
"nonproprietary_name": "pegunigalsidase alfa",
"start_marketing_date": "20230523",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code A16AB20.
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