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United States · US · US:42358-329_bfd40890-37a6-4847-9b2d-6e6966b6af01
Zycubo
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSentynl Therapeutics, Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1142358329011 VIAL, GLASS in 1 CARTON (42358-329-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS
Annotations
UNII (FDA Substance ID)
9078K3MO9U
COPPER HISTIDINATE
Orange Book
N211241
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "9078K3MO9U",
"rxcui": null,
"inchikey": "UUYDYUZBCIHUFZ-MDTVQASCSA-L",
"display_name": "COPPER HISTIDINATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "SUBCUTANEOUS",
"spl_meta": {
"e3aeefc2-f44d-4337-9c2e-3dba44a89e48": {
"match": "brand_token",
"title": "ZYCUBO (COPPER HISTIDINATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SENTYNL THERAPEUTICS, INC.]",
"spl_version": "2",
"published_date": "2026-01-23"
}
},
"productid": "42358-329_bfd40890-37a6-4847-9b2d-6e6966b6af01",
"productndc": "42358-329",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "211241",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "2.9MG/VIAL",
"product_no": "001",
"approval_date": "Jan 12, 2026"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "COPPER HISTIDINATE",
"proprietary_name": "Zycubo",
"active_ingred_unit": "mg/1",
"application_number": "NDA211241",
"marketing_category": "NDA",
"nonproprietary_name": "copper histidinate",
"start_marketing_date": "20260112",
"active_numerator_strength": "2.9"
}Access this data programmatically
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