Xyosted (testosterone enanthate) NDC 54436-275

NDC codes

FDA NDC Directory

Product NDC (as listed)54436-275Labeler and product segments. Claims need a package NDC.

Product NDC at billing width54436-0275Add 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
54436-275-01	54436027501	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	54436027504	4 SYRINGE in 1 CARTON (54436-275-04) / .5 mL in 1 SYRINGE (54436-275-02)Marketed from Nov 15, 2018
54436-275-05	54436027505	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.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 209863
Marketing start: Nov 15, 2018
Listing expires: Dec 31, 2027
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.

How CPT relates to drug billing

NDC on a medical claim

N454436027501 followed by a unit qualifier and the quantity

Package 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under NDA 209863

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

FDA NDC Directory listings under NDA 209863
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