Prescription drug · ANDA
Testopel (testosterone) NDC 66887-004
Testosterone 75 mg/1 · Pellet · Subcutaneous · Endo USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66887-004-10 | 66887000410 | 10 AMPULE in 1 BOX (66887-004-10) / 1 PELLET in 1 AMPULE (66887-004-01)Marketed from Oct 31, 2014 | |
| 66887-004-20 | 66887000420 | 100 AMPULE in 1 BOX (66887-004-20) / 1 PELLET in 1 AMPULE (66887-004-01)Marketed from Oct 31, 2014 |
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)
- Testopel
- Generic name (nonproprietary)
- testosterone
- Active ingredients
- Testosterone — 75 mg/1
- Dosage form
- Pellet
- Route
- Subcutaneous
- Labeler
- Endo USA, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 080911
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
- Identifiers
- Product ID 66887-004_0a13cf12-e51e-4d3d-a7c4-ea74712e6db2SPL ID 0a13cf12-e51e-4d3d-a7c4-ea74712e6db2SPL set ID 03b9c0b1-5884-11e4-8ed6-0800200c9a66RxCUI 318240, 404405UNII 3XMK78S47O
- 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
N466887000410followed by a unit qualifier and the quantityPackage 66887-0004-10. 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 MALES Androgens are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone. a. Primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testes syndrome; or orchiectomy. b. Hypogonadotropic hypogonadism (congenital or acquired) - gonadotropic LHRH deficiency, or pituitary - hypothalamic injury from tumors, trauma or radiation. If the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sex characteristics. Prolonged androgen treatment will be required to…
Excerpt only. Read the full label for complete information.