Azmiro (testosterone cypionate) NDC 24338-056

NDC codes

FDA NDC Directory

Product NDC (as listed)24338-056Labeler and product segments. Claims need a package NDC.

Product NDC at billing width24338-0056Add 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
24338-056-01	24338005601	1 VIAL in 1 CARTON (24338-056-01) / 1 mL in 1 VIALMarketed from Oct 4, 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): Azmiro
Generic name (nonproprietary): testosterone cypionate
Active ingredients: Testosterone cypionate — 200 mg/mL
Dosage form: Injection, Solution
Route: Intramuscular
Labeler: Azurity Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 216318
Marketing start: Oct 4, 2024
Listing expires: Dec 31, 2026
DEA schedule: CIII
Other FDA classes: Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
Identifiers: Product ID 24338-056_5cf15fb2-1ba1-4295-9ddf-e98434ccd1c2SPL ID 5cf15fb2-1ba1-4295-9ddf-e98434ccd1c2SPL set ID 235b5625-570d-3fba-e063-6394a90aa2d1RxCUI 2047882, 2694309, 2694316, 2694320UNII M0XW1UBI14UPC 0324338055014
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

N424338005601 followed by a unit qualifier and the quantity

Package 24338-0056-01. 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 Jul 25, 2025.

Indications (excerpt from the label)

AZMIRO is indicated for testosterone replacement therapy in males in 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; or orchiectomy, Klinefelter’s syndrome, or toxic damage from alcohol or heavy metals, 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 [ see Dosage and Administration ( 2.2 ) ]. • Hypogonadotropic hypogonadism …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 216318

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

FDA NDC Directory listings under NDA 216318
Product	Strength	Form · route	Labeler	Product NDC
Azmirotestosterone cypionate	Testosterone cypionate 200 mg/mL	Injection, SolutionIntramuscular	Azurity Pharmaceuticals, Inc.	24338-055