Prescription drug · ANDA
Testosterone Cypionate NDC 69097-802
Testosterone cypionate 200 mg/mL · Injection, Solution · Intramuscular · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-802-32 | 69097080232 | 1 VIAL, GLASS in 1 CARTON (69097-802-32) / 1 mL in 1 VIAL, GLASSMarketed from Mar 26, 2019 | |
| 69097-802-37 | 69097080237 | 1 VIAL, GLASS in 1 CARTON (69097-802-37) / 10 mL in 1 VIAL, GLASSMarketed from Mar 26, 2019 |
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)
- Testosterone Cypionate
- Generic name (nonproprietary)
- testosterone cypionate
- Active ingredients
- Testosterone cypionate — 200 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular
- Labeler
- Cipla USA Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091244
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
- Identifiers
- Product ID 69097-802_5a71d184-5faa-444f-8d00-2f2531f342dbSPL ID 5a71d184-5faa-444f-8d00-2f2531f342dbSPL set ID b8ac5e07-b7e3-4a60-b0d1-8b1f3ad0c478RxCUI 835840, 2047882UNII M0XW1UBI14UPC 0369097802325, 0369097802370
- 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
N469097080232followed by a unit qualifier and the quantityPackage 69097-0802-32. 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, USP is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (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 no…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091244
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 | InjectionIntramuscular | Hikma Pharmaceuticals USA Inc. | 0143-9726 |
| Testosterone Cypionate | Testosterone cypionate 200 mg/mL | InjectionIntramuscular | Proficient Rx LP | 63187-647 |
| Testosterone Cypionate | Testosterone cypionate 200 mg/mL | Injection, SolutionIntramuscular | Padagis US LLC | 0574-0827 |
| Testosterone Cypionate | Testosterone cypionate 200 mg/mL | Injection, SolutionIntramuscular | Asclemed USA, Inc. | 76420-741 |
| Testosterone Cypionate | Testosterone cypionate 200 mg/mL | Injection, SolutionIntramuscular | Asclemed USA, Inc. | 76420-746 |
| Testosterone Cypionate | Testosterone cypionate 200 mg/mL | Injection, SolutionIntramuscular | A-S Medication Solutions | 50090-4920 |
| Testosterone Cypionate | Testosterone cypionate 200 mg/mL | Injection, SolutionIntramuscular | Bryant Ranch Prepack | 72162-1119 |
| Testosterone Cypionate | Testosterone cypionate 200 mg/mL | Injection, SolutionIntramuscular | Bryant Ranch Prepack | 63629-8705 |
| Testosterone Cypionate | Testosterone cypionate 200 mg/mL | Injection, SolutionIntramuscular | Bryant Ranch Prepack | 63629-8706 |
| Testosterone Cypionate | Testosterone cypionate 200 mg/mL | InjectionIntramuscular | Hikma Pharmaceuticals USA Inc. | 0143-9659 |
| Testosterone Cypionate | Testosterone cypionate 200 mg/mL | Injection, SolutionIntramuscular | ASCLEMED USA INC. | 87063-272 |
| Testosterone Cypionate | Testosterone cypionate 200 mg/mL | Injection, SolutionIntramuscular | Bryant Ranch Prepack | 71335-2838 |
| Testosterone Cypionate | Testosterone cypionate 200 mg/mL | InjectionIntramuscular | Hikma Pharmaceuticals USA Inc. | 0143-9005 |
| Testosterone Cypionate | Testosterone cypionate 200 mg/mL | InjectionIntramuscular | Proficient Rx LP | 71205-289 |