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United States · US · US:73606-010_0a1c9d84-182a-4e4c-8adf-74a3ca2db038
Empaveli
Orange BookUNIISPLATC L04AJ03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerApellis Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeL04AJ03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1173606010011 VIAL in 1 CARTON (73606-010-01) / 20 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
TO3JYR3BOU
PEGCETACOPLAN
RxCUI 2557372
Orange Book
N215014
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "TO3JYR3BOU",
"rxcui": "2557372",
"inchikey": null,
"display_name": "PEGCETACOPLAN",
"substance_type": "protein",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "SUBCUTANEOUS",
"spl_meta": {
"c23d89e9-b00b-4520-e053-2995a90a95af": {
"match": "brand_token",
"title": "EMPAVELI (PEGCETACOPLAN) INJECTION, SOLUTION [APELLIS PHARMACEUTICALS, INC.]",
"spl_version": "13",
"published_date": "2025-08-04"
}
},
"productid": "73606-010_0a1c9d84-182a-4e4c-8adf-74a3ca2db038",
"productndc": "73606-010",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "215014",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "1080MG/20ML (54MG/ML)",
"product_no": "001",
"approval_date": "May 14, 2021"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PEGCETACOPLAN",
"proprietary_name": "Empaveli",
"active_ingred_unit": "mg/20mL",
"application_number": "NDA215014",
"marketing_category": "NDA",
"nonproprietary_name": "Pegcetacoplan",
"start_marketing_date": "20210514",
"active_numerator_strength": "1080"
}Related drugs
Other records sharing ATC code L04AJ03.
- PLAspaveliSwedish Orphan Biovitrum AB (publ)
- NOAspaveliApellis Ireland Limited
- 🇨🇭AspaveliSwedish Orphan Biovitrum AG
- 🇨🇭Aspaveli
- FIASPAVELISwedish Orphan Biovitrum AB (publ)
- CZASPAVELISwedish Orphan Biovitrum AB (publ), Stockholm
- CZASPAVELISwedish Orphan Biovitrum AB (publ), Stockholm
- DKASPAVELISwedish Orphan Biovitrum AB
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