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 | 0014397500100143975001 | 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
- Labeler
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0143
- 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.
About NDC 0143-9750
- What is NDC 0143-9750?
- 0143-9750 is the product NDC for Testosterone Enanthate, Testosterone enanthate 200 mg/mL injection, solution, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Testosterone Enanthate.
- What is the active ingredient?
- Testosterone enanthate.
- Who is the labeler?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0143. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Testosterone Enanthate?
- 1 other product NDC are listed under this name. See all Testosterone Enanthate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Testosterone Enanthate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Testosterone Enanthate | Testosterone enanthate 200 mg/mL | Injection, SolutionIntramuscular | Eugia US LLC | 55150-336 | 55150-0336-01 |