Prescription drug · ANDA
Depo-Testosterone (Testosterone cypionate) NDC 76420-425
Testosterone cypionate 100 mg/mL · Injection, Solution · Intramuscular · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-425-10 | 7642004251076420042510 | 1 VIAL in 1 CARTON (76420-425-10) / 10 mL in 1 VIALMarketed from Aug 8, 2025 |
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)
- Depo-Testosterone
- Generic name (nonproprietary)
- testosterone cypionate
- Active ingredients
- Testosterone cypionate — 100 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular
- Labeler
- Asclemed USA, Inc.NDC labeler code 76420
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 085635
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
- Identifiers
- Product ID 76420-425_3d534b61-bcc6-9c44-e063-6294a90a1b6bSPL ID 3d534b61-bcc6-9c44-e063-6294a90a1b6bSPL set ID 2f72be32-ede6-44d9-88a0-0653b53a3e47RxCUI 835829, 835831UNII M0XW1UBI14
- 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
N476420042510followed by a unit qualifier and the quantityPackage 76420-0425-10. 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)
INDICATIONS AND USAGE DEPO-Testosterone Injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. 1. Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. 2. Hypogonadotropic hypogonadism (congenital or acquired) - gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. Safety and efficacy of DEPO-Testosterone (testosterone cypionate) in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.
Excerpt only. Read the full label for complete information.
About NDC 76420-425
- What is NDC 76420-425?
- 76420-425 is the product NDC for Depo-Testosterone (testosterone cypionate), Testosterone cypionate 100 mg/mL injection, solution, listed with the FDA by Asclemed USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Depo-Testosterone (Testosterone cypionate).
- What is the active ingredient?
- Testosterone cypionate.
- Who is the labeler?
- Asclemed USA, Inc., NDC labeler code 76420. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Depo-Testosterone?
- 4 other product NDCs are listed under this name. See all Depo-Testosterone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Depo-Testosterone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Depo-Testosteronetestosterone cypionate | Testosterone cypionate 100 mg/mL | Injection, SolutionIntramuscular | Pharmacia & Upjohn Company LLC | 0009-0085 | 00009-0085-10 |
| Depo-Testosteronetestosterone cypionate | Testosterone cypionate 200 mg/mL | Injection, SolutionIntramuscular | Pharmacia & Upjohn Company LLC | 0009-0086 | 00009-0086-01 |
| Depo-Testosteronetestosterone cypionate | Testosterone cypionate 100 mg/mL | Injection, SolutionIntramuscular | Pharmacia & Upjohn Company LLC | 0009-0347 | 00009-0347-02 |
| Depo-Testosteronetestosterone cypionate | Testosterone cypionate 200 mg/mL | Injection, SolutionIntramuscular | Pharmacia & Upjohn Company LLC | 0009-0417 | 00009-0417-0100009-0417-02 |
Other NDCs under ANDA 085635
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 |
|---|---|---|---|---|
| Depo-Testosteronetestosterone cypionate | Testosterone cypionate 100 mg/mL | Injection, SolutionIntramuscular | Pharmacia & Upjohn Company LLC | 0009-0085 |
| Depo-Testosteronetestosterone cypionate | Testosterone cypionate 200 mg/mL | Injection, SolutionIntramuscular | Pharmacia & Upjohn Company LLC | 0009-0086 |
| Depo-Testosteronetestosterone cypionate | Testosterone cypionate 100 mg/mL | Injection, SolutionIntramuscular | Pharmacia & Upjohn Company LLC | 0009-0347 |
| Depo-Testosteronetestosterone cypionate | Testosterone cypionate 200 mg/mL | Injection, SolutionIntramuscular | Pharmacia & Upjohn Company LLC | 0009-0417 |
| Testosterone Cypionate | Testosterone cypionate 100 mg/mL | Injection, SolutionIntramuscular | Hospira, Inc. | 0409-6557 |
| Testosterone Cypionate | Testosterone cypionate 200 mg/mL | Injection, SolutionIntramuscular | Hospira, Inc. | 0409-6562 |