Prescription drug · NDA
Kyzatrex (Testosterone undecanoate) NDC 80603-105
Testosterone undecanoate 200 mg/1 · Capsule, Liquid filled · Oral · Marius Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80603-105-11 | 8060301051180603010511 | 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (80603-105-11)Marketed from Jul 27, 2022 | |
| 80603-105-22 | 8060301052280603010522 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (80603-105-22)Marketed from Jul 27, 2022 | |
| 80603-105-33 | 8060301053380603010533 | 60 CAPSULE, LIQUID FILLED in 1 BOTTLE (80603-105-33)Marketed from Sep 25, 2023 |
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 — 200 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Marius PharmaceuticalsNDC labeler code 80603
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 213953
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
- Identifiers
- Product ID 80603-105_5d1ef1d8-6e15-ffeb-e063-6294a90abfd8SPL ID 5d1ef1d8-6e15-ffeb-e063-6294a90abfd8
- 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
N480603010511followed by a unit qualifier and the quantityPackage 80603-0105-11. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 80603-105
- What is NDC 80603-105?
- 80603-105 is the product NDC for Kyzatrex (testosterone undecanoate), Testosterone undecanoate 200 mg/1 capsule, liquid filled, listed with the FDA by Marius Pharmaceuticals. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Kyzatrex (Testosterone undecanoate).
- What is the active ingredient?
- Testosterone undecanoate.
- Who is the labeler?
- Marius Pharmaceuticals, NDC labeler code 80603. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Kyzatrex?
- 2 other product NDCs are listed under this name. See all Kyzatrex NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Kyzatrex products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Kyzatrextestosterone undecanoate | Testosterone undecanoate 50 mg/1 | Capsule, Liquid filledOral | Marius Pharmaceuticals | 80603-107 | 80603-0107-44 |
| Kyzatrextestosterone undecanoate | Testosterone undecanoate 150 mg/1 | Capsule, Liquid filledOral | Marius Pharmaceuticals | 80603-103 | 80603-0103-1180603-0103-22 |
Other NDCs under NDA 213953
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| 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 50 mg/1 | Capsule, Liquid filledOral | Marius Pharmaceuticals | 80603-107 |