Prescription drug · ANDA
Depo-Testosterone (testosterone cypionate) NDC 0009-0086
Testosterone cypionate 200 mg/mL · Injection, Solution · Intramuscular · Pharmacia & Upjohn Company LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0009-0086-01 | 00009008601 | 1 VIAL in 1 CARTON (0009-0086-01) / 1 mL in 1 VIALMarketed from Jul 1, 2014 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 200 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular
- 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 0009-0086_d47c9c86-9b65-4daa-b5dd-63975d19e154SPL ID d47c9c86-9b65-4daa-b5dd-63975d19e154SPL set ID 735b5bf3-4464-412c-a072-1bd02f2e5380RxCUI 835829, 835831, 835840, 835842UNII 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
N400009008601followed by a unit qualifier and the quantityPackage 00009-0086-01. 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)
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.
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 200 mg/mL | Injection, SolutionIntramuscular | Pharmacia & Upjohn Company LLC | 0009-0417 |
| Depo-Testosteronetestosterone cypionate | Testosterone cypionate 100 mg/mL | Injection, SolutionIntramuscular | Pharmacia & Upjohn Company LLC | 0009-0347 |
| Depo-Testosteronetestosterone cypionate | Testosterone cypionate 100 mg/mL | Injection, SolutionIntramuscular | Pharmacia & Upjohn Company LLC | 0009-0085 |
| 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 |
| Depo-Testosteronetestosterone cypionate | Testosterone cypionate 100 mg/mL | Injection, SolutionIntramuscular | Asclemed USA, Inc. | 76420-425 |