Prescription drug · ANDA
Testosterone Cypionate NDC 50090-4147
Testosterone cypionate 200 mg/mL · Injection, Solution · Intramuscular · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-4147-0 | 50090414700 | 1 VIAL, GLASS in 1 CARTON (50090-4147-0) / 10 mL in 1 VIAL, GLASSMarketed from Feb 19, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Testosterone Cypionate
- Generic name (nonproprietary)
- testosterone cypionate
- Active ingredients
- Testosterone cypionate — 200 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040530
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
- Identifiers
- Product ID 50090-4147_1ed29921-46ad-4b3a-abca-ba84d306909bSPL ID 1ed29921-46ad-4b3a-abca-ba84d306909bSPL set ID 2321a581-2e33-4233-a1d4-0711b90e3c57RxCUI 835840UNII 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
N450090414700followed by a unit qualifier and the quantityPackage 50090-4147-00. 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 Testosterone cypionate 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 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 040530
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 |
|---|---|---|---|---|
| Testosterone Cypionate | Testosterone cypionate 200 mg/mL | Injection, SolutionIntramuscular | Asclemed USA, Inc. | 76420-645 |
| Testosterone Cypionate | Testosterone cypionate 200 mg/mL | Injection, SolutionIntramuscular | Padagis US LLC | 0574-0820 |
| Testosterone Cypionate | Testosterone cypionate 200 mg/mL | Injection, SolutionIntramuscular | Bryant Ranch Prepack | 71335-2470 |
| Testosterone Cypionate | Testosterone cypionate 200 mg/mL | Injection, SolutionIntramuscular | Bryant Ranch Prepack | 71335-2473 |
| Testosterone Cypionate | Testosterone cypionate 200 mg/mL | Injection, SolutionIntramuscular | Bryant Ranch Prepack | 72162-2375 |