Prescription drug · ANDA
testosterone cypionate NDC 54288-156
Testosterone cypionate 200 mg/mL · Injection, Solution · Intramuscular · BPI Labs LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54288-156-01 | 5428801560154288015601 | 1 VIAL, SINGLE-DOSE in 1 CARTON (54288-156-01) / 1 mL in 1 VIAL, SINGLE-DOSEMarketed from Sep 14, 2026 |
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
- BPI Labs LLCNDC labeler code 54288
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219478
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
- Identifiers
- Product ID 54288-156_5ea88213-31ad-4862-8d67-af84e4f089ccSPL ID 5ea88213-31ad-4862-8d67-af84e4f089cc
- 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
N454288015601followed by a unit qualifier and the quantityPackage 54288-0156-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 54288-156
- What is NDC 54288-156?
- 54288-156 is the product NDC for testosterone cypionate, Testosterone cypionate 200 mg/mL injection, solution, listed with the FDA by BPI Labs LLC. 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?
- BPI Labs LLC, NDC labeler code 54288. 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 | 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 | 50090-7585 | 50090-7585-00 |
| 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 | 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 |
| Testosterone Cypionate | Testosterone cypionate 2000 mg/10mL | Injection, SolutionIntramuscular | Eugia US LLC | 55150-278 | 55150-0278-01 |
Other NDCs under ANDA 219478
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 | Injection, SolutionIntramuscular | BPI Labs LLC | 54288-150 |
| testosterone cypionate | Testosterone cypionate 200 mg/mL | Injection, SolutionIntramuscular | Ajenat Pharmaceuticals LLC | 82983-424 |
| testosterone cypionate | Testosterone cypionate 200 mg/mL | Injection, SolutionIntramuscular | Ajenat Pharmaceuticals LLC | 82983-425 |