zycubo

Generic: copper histidinate

Labeler: sentynl therapeutics, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zycubo
Generic Name copper histidinate
Labeler sentynl therapeutics, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

copper histidinate 2.9 mg/1

Manufacturer
Sentynl Therapeutics, Inc.

Identifiers & Regulatory

Product NDC 42358-329
Product ID 42358-329_bfd40890-37a6-4847-9b2d-6e6966b6af01
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA211241
Listing Expiration 2027-12-31
Marketing Start 2026-01-12

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42358329
Hyphenated Format 42358-329

Supplemental Identifiers

RxCUI
2732219 2732224
UPC
0342358329014
UNII
9078K3MO9U

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name zycubo (source: ndc)
Generic Name copper histidinate (source: ndc)
Application Number NDA211241 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 2.9 mg/1
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (42358-329-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS
source: ndc

Packages (1)

42358-329-01 1 VIAL, GLASS in 1 CARTON (42358-329-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS

Ingredients (1)

copper histidinate (2.9 mg/1)

Linked Drug Pages (1)

Zycubo ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "bfd40890-37a6-4847-9b2d-6e6966b6af01", "openfda": {"upc": ["0342358329014"], "unii": ["9078K3MO9U"], "rxcui": ["2732219", "2732224"], "spl_set_id": ["e3aeefc2-f44d-4337-9c2e-3dba44a89e48"], "manufacturer_name": ["Sentynl Therapeutics, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (42358-329-01)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS", "package_ndc": "42358-329-01", "marketing_start_date": "20260126"}], "brand_name": "Zycubo", "product_id": "42358-329_bfd40890-37a6-4847-9b2d-6e6966b6af01", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "product_ndc": "42358-329", "generic_name": "copper histidinate", "labeler_name": "Sentynl Therapeutics, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zycubo", "active_ingredients": [{"name": "COPPER HISTIDINATE", "strength": "2.9 mg/1"}], "application_number": "NDA211241", "marketing_category": "NDA", "marketing_start_date": "20260112", "listing_expiration_date": "20271231"}