Prescription drug · NDA
Xyosted (Testosterone enanthate) NDC 54436-275
Testosterone enanthate 75 mg/.5mL · Injection · Subcutaneous · Antares Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54436-275-01 | 5443602750154436027501 | 1 SYRINGE in 1 CARTON (54436-275-01) / .5 mL in 1 SYRINGE (54436-275-03)Marketed from Nov 15, 2018 · Sample package | |
| 54436-275-04 | 5443602750454436027504 | 4 SYRINGE in 1 CARTON (54436-275-04) / .5 mL in 1 SYRINGE (54436-275-02)Marketed from Nov 15, 2018 | |
| 54436-275-05 | 5443602750554436027505 | 1 SYRINGE in 1 CARTON (54436-275-05) / .5 mL in 1 SYRINGE (54436-275-02)Marketed from Jan 8, 2024 |
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)
- Xyosted
- Generic name (nonproprietary)
- testosterone enanthate
- Active ingredients
- Testosterone enanthate — 75 mg/.5mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Labeler
- Antares Pharma, Inc.NDC labeler code 54436
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209863
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
- Identifiers
- Product ID 54436-275_c8d74eb6-fa94-446a-8307-091436a536dcSPL ID c8d74eb6-fa94-446a-8307-091436a536dcSPL set ID 8a3d204c-be26-49e0-8599-0ac12a272e81RxCUI 2099681, 2099686, 2099689, 2099691, 2099695, 2099697UNII 7Z6522T8N9
- 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 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.
- NDC on a medical claim
N454436027501followed by a unit qualifier and the quantityPackage 54436-0275-01. 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 .
Indications (excerpt from the label)
XYOSTED (testosterone enanthate) injection is an androgen 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 cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormo…
Excerpt only. Read the full label for complete information.
About NDC 54436-275
- What is NDC 54436-275?
- 54436-275 is the product NDC for Xyosted (testosterone enanthate), Testosterone enanthate 75 mg/.5mL injection, listed with the FDA by Antares Pharma, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Xyosted (Testosterone enanthate).
- What is the active ingredient?
- Testosterone enanthate.
- Who is the labeler?
- Antares Pharma, Inc., NDC labeler code 54436. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Xyosted?
- 2 other product NDCs are listed under this name. See all Xyosted NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Xyosted products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Xyostedtestosterone enanthate | Testosterone enanthate 100 mg/.5mL | InjectionSubcutaneous | Antares Pharma, Inc. | 54436-200 | 54436-0200-0154436-0200-0454436-0200-05 |
| Xyostedtestosterone enanthate | Testosterone enanthate 50 mg/.5mL | InjectionSubcutaneous | Antares Pharma, Inc. | 54436-250 | 54436-0250-0154436-0250-04 |
Other NDCs under NDA 209863
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 |
|---|---|---|---|---|
| Xyostedtestosterone enanthate | Testosterone enanthate 100 mg/.5mL | InjectionSubcutaneous | Antares Pharma, Inc. | 54436-200 |
| Xyostedtestosterone enanthate | Testosterone enanthate 50 mg/.5mL | InjectionSubcutaneous | Antares Pharma, Inc. | 54436-250 |