Prescription drug · ANDA
Testosterone Cypionate NDC 0143-9005
Testosterone cypionate 200 mg/mL · Injection · Intramuscular · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9005-01 | 0014390050100143900501 | 1 VIAL in 1 CARTON (0143-9005-01) / 10 mL in 1 VIALMarketed from Nov 22, 2021 |
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 Cypionate
- Generic name (nonproprietary)
- testosterone cypionate
- Active ingredients
- Testosterone cypionate — 200 mg/mL
- Dosage form
- Injection
- 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 091244
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
- Identifiers
- Product ID 0143-9005_9aa4f810-6b6e-4959-bfa3-b15b088ef380SPL ID 9aa4f810-6b6e-4959-bfa3-b15b088ef380SPL set ID 5ca67491-4b30-4a47-af0a-be250215d1f0RxCUI 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
N400143900501followed by a unit qualifier and the quantityPackage 00143-9005-01. 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 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.
About NDC 0143-9005
- What is NDC 0143-9005?
- 0143-9005 is the product NDC for Testosterone Cypionate, Testosterone cypionate 200 mg/mL injection, 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 Cypionate.
- What is the active ingredient?
- Testosterone cypionate.
- 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 Cypionate?
- 53 other product NDCs are listed under this name. See all Testosterone Cypionate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Testosterone Cypionate 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 cypionate | Testosterone cypionate 200 mg/mL | Injection, SolutionIntramuscular | BPI Labs LLC | 54288-150 | 54288-0150-0154288-0150-10 |
| testosterone cypionate | Testosterone cypionate 200 mg/mL | Injection, SolutionIntramuscular | BPI Labs LLC | 54288-156 | 54288-0156-01 |
| testosterone cypionate | Testosterone cypionate 200 mg/mL | Injection, SolutionIntramuscular | Ajenat Pharmaceuticals LLC | 82983-424 | 82983-0424-01 |
| testosterone cypionate | Testosterone cypionate 200 mg/mL | Injection, SolutionIntramuscular | Ajenat Pharmaceuticals LLC | 82983-425 | 82983-0425-01 |
| Testosterone Cypionate | Testosterone cypionate 200 mg/mL | InjectionIntramuscular | REMEDYREPACK INC. | 70518-4538 | 70518-4538-00 |
| testosterone cypionate | Testosterone cypionate 200 mg/mL | Injection, SolutionIntramuscular | A-S Medication Solutions | 50090-7584 | 50090-7584-00 |
| testosterone cypionate | Testosterone cypionate 200 mg/mL | Injection, SolutionIntramuscular | A-S Medication Solutions | 50090-7585 | 50090-7585-00 |
| testosterone cypionate | Testosterone cypionate 200 mg/mL | Injection, SolutionIntramuscular | NorthStar Rx LLC | 72603-286 | 72603-0286-01 |
| Testosterone Cypionate | Testosterone cypionate 1000 mg/10mL | Injection, SolutionIntramuscular | Eugia US LLC | 55150-276 | 55150-0276-01 |
| Testosterone Cypionate | Testosterone cypionate 200 mg/mL | Injection, SolutionIntramuscular | Eugia US LLC | 55150-277 | 55150-0277-01 |
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. | 0143-9659 |
| 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 | Injection, SolutionIntramuscular | Bryant Ranch Prepack | 72162-1119 |
| 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. | 87063-272 |
| Testosterone Cypionate | Testosterone cypionate 200 mg/mL | InjectionIntramuscular | Proficient Rx LP | 71205-289 |
| Testosterone Cypionate | Testosterone cypionate 200 mg/mL | Injection, SolutionIntramuscular | Bryant Ranch Prepack | 71335-2838 |
| Testosterone Cypionate | Testosterone cypionate 200 mg/mL | Injection, SolutionIntramuscular | Cipla USA Inc. | 69097-802 |
| Testosterone Cypionate | Testosterone cypionate 200 mg/mL | Injection, SolutionIntramuscular | A-S Medication Solutions | 50090-4920 |
| 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 | 50090-8127 |