FDA.reportPublic FDA data

ZYCUBO ® (Copper Histidine) for Injection

Manufacturer
Zydus Lifesciences Limited
Effective date
2026-01-27
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
monthly-update
Hydrated at
2026-06-03 17:55:31

Label at a glance#

ProductZYCUBO
Active ingredientCOPPER HISTIDINATE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1977-1

ZYCUBO (copper histidinate) for injection

2.9 mg/vial

For subcutaneous use

Single-Dose Vial

Discard unused portion after each single use.

Do not administer more than one dose from the vial.

Rx only

2.9 mL
2.9 mL

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70771-197770771-1977-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
COPPER HISTIDINATE9078K3MO9UACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
de97d0e2-2076-47d1-b87e-1a903fda4778a1c4fdde-0ffb-4742-b042-b0e29460cf132026-01-27Exact identifier
spl id: de97d0e2-2076-47d1-b87e-1a903fda4778
spl set id: a1c4fdde-0ffb-4742-b042-b0e29460cf13

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.