Kyzatrex (testosterone undecanoate) NDC 80603-107

NDC codes

FDA NDC Directory

Product NDC (as listed)80603-107Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80603-0107Add 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
80603-107-44	80603010744	30 CAPSULE, LIQUID FILLED in 1 BOTTLE (80603-107-44)Marketed from Aug 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): Kyzatrex
Generic name (nonproprietary): testosterone undecanoate
Active ingredients: Testosterone undecanoate — 50 mg/1
Dosage form: Capsule, Liquid filled
Route: Oral
Labeler: Marius Pharmaceuticals
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 213953
Marketing start: Aug 18, 2026
Listing expires: Dec 31, 2027
DEA schedule: CIII
Other FDA classes: Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
Identifiers: Product ID 80603-107_59faa623-cfa9-e677-e063-6394a90a651eSPL ID 59faa623-cfa9-e677-e063-6394a90a651eSPL set ID 7f7167a7-2a25-47e2-acf5-33f499fce971RxCUI 2609597, 2609603, 2609605, 2609607, 2609609, 2609611, 2751561, 2751563UNII H16A5VCT9C
Pharmacologic class: Androgen

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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N480603010744 followed by a unit qualifier and the quantity

Package 80603-0107-44. 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 Aug 26, 2026.

Indications (excerpt from the label)

KYZATREX® is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (folliclestimulating hormone (FSH), luteinizing hormone (LH)) above the normal range. Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) d…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 213953

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 213953
Product	Strength	Form · route	Labeler	Product NDC
Kyzatrextestosterone undecanoate	Testosterone undecanoate 150 mg/1	Capsule, Liquid filledOral	Marius Pharmaceuticals	80603-103
Kyzatrextestosterone undecanoate	Testosterone undecanoate 200 mg/1	Capsule, Liquid filledOral	Marius Pharmaceuticals	80603-105