What is NDC 42358-329?

42358-329 is the product NDC for Zycubo (copper histidinate), Copper histidinate 2.9 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by Sentynl Therapeutics, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Sentynl Therapeutics, Inc., NDC labeler code 42358. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Zycubo?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Zycubo NDC 42358-329 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)42358-329Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42358-0329Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
42358-329-01	42358032901	1 VIAL, GLASS in 1 CARTON (42358-329-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASSMarketed from Jan 26, 2026

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Zycubo
Generic name (nonproprietary): copper histidinate
Active ingredients: Copper histidinate — 2.9 mg/1
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Subcutaneous
Labeler: Sentynl Therapeutics, Inc.NDC labeler code 42358
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 211241
Marketing start: Jan 12, 2026
Listing expires: Dec 31, 2027
Identifiers: Product ID 42358-329_bfd40890-37a6-4847-9b2d-6e6966b6af01SPL ID bfd40890-37a6-4847-9b2d-6e6966b6af01SPL set ID e3aeefc2-f44d-4337-9c2e-3dba44a89e48RxCUI 2732219, 2732224UNII 9078K3MO9UUPC 0342358329014

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N442358032901 followed by a unit qualifier and the quantity

Package 42358-0329-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jan 12, 2026.

Indications (excerpt from the label)

ZYCUBO is indicated for the treatment of Menkes disease in pediatric patients. ZYCUBO is a copper replacement product indicated for the treatment of Menkes disease in pediatric patients. ( 1 ) Limitations of Use ZYCUBO is not indicated for the treatment of Occipital Horn Syndrome. ( 1 ) Limitations of Use ZYCUBO is not indicated for the treatment of Occipital Horn Syndrome.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42358-329

What is NDC 42358-329?: 42358-329 is the product NDC for Zycubo (copper histidinate), Copper histidinate 2.9 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by Sentynl Therapeutics, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Zycubo (Copper histidinate).
What is the active ingredient?: Copper histidinate.
Who is the labeler?: Sentynl Therapeutics, Inc., NDC labeler code 42358. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Zycubo?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Zycubo (Copper histidinate) NDC 42358-329