Prescription drug · ANDA
Tirofiban NDC 55150-430
Tirofiban hydrochloride 12.5 mg/250mL · Injection, Solution · Intravenous · Eugia US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55150-430-01 | 55150043001 | 1 POUCH in 1 CARTON (55150-430-01) / 1 BAG in 1 POUCH / 250 mL in 1 BAGMarketed from May 1, 2023 |
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)
- Tirofiban
- Generic name (nonproprietary)
- tirofiban
- Active ingredients
- Tirofiban hydrochloride — 12.5 mg/250mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Eugia US LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216379
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Platelet Aggregation (Physiologic effect)
- Identifiers
- Product ID 55150-430_1751523a-e22e-4faf-bdb1-c850afe2fd36SPL ID 1751523a-e22e-4faf-bdb1-c850afe2fd36SPL set ID d554acff-22e9-4f28-b826-ee1b91daa2dfRxCUI 1737466, 1737471UNII 6H925F8O5JUPC 0355150430017, 0355150429011
- Pharmacologic class
- Platelet Aggregation Inhibitor
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
N455150043001followed by a unit qualifier and the quantityPackage 55150-0430-01. 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)
Tirofiban hydrochloride injection is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS). Tirofiban hydrochloride injection is a platelet aggregation inhibitor indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS). ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216379
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 |
|---|---|---|---|---|
| Tirofiban | Tirofiban hydrochloride 5 mg/100mL | Injection, SolutionIntravenous | Eugia US LLC | 55150-429 |