Prescription drug · ANDA
Testosterone Enanthate NDC 0143-9750
Testosterone enanthate 200 mg/mL · Injection, Solution · Intramuscular · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9750-01 | 00143975001 | 5 mL in 1 VIAL, MULTI-DOSE (0143-9750-01)Marketed from Sep 18, 2012 |
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)
- Testosterone Enanthate
- Generic name (nonproprietary)
- testosterone enanthate
- Active ingredients
- Testosterone enanthate — 200 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091120
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
- Identifiers
- Product ID 0143-9750_8d67aa07-833f-4be7-8a7e-e49e19f49949SPL ID 8d67aa07-833f-4be7-8a7e-e49e19f49949SPL set ID e89d6458-428c-4256-97a3-f1fa851293c1RxCUI 835809UNII 7Z6522T8N9
- 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
N400143975001followed by a unit qualifier and the quantityPackage 00143-9750-01. 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 Males Testosterone Enanthate Injection, USP is indicated for replacement therapy in conditions associated with a 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. (Appropriate adrenal cortical and thyroid hormone replacement therapy are still necessary, however, and are actually of primary importance.) If the above …
Excerpt only. Read the full label for complete information.