ZYCUBO- copper histidinate injection, powder, lyophilized, for solution

ZYCUBO by

Drug Labeling and Warnings

ZYCUBO by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED

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

INGREDIENTS AND APPEARANCE

ZYCUBO 
copper histidinate injection, powder, lyophilized, for solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1977
Route of Administration	SUBCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COPPER HISTIDINATE (UNII: 9078K3MO9U) (COPPER HISTIDINATE - UNII:9078K3MO9U)	COPPER HISTIDINATE	2.9 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1977-1	1 in 1 CARTON	01/26/2026
1		1 in 1 VIAL, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA211241	01/12/2026

Labeler - Zydus Lifesciences Limited (918596198)