Prescription drug · NDA
Aggrastat (Tirofiban) NDC 25208-001
Tirofiban hydrochloride 3.75 mg/15mL · Injection, Solution · Intravenous · Medicure International Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25208-001-04 | 2520800010425208000104 | 1 VIAL, GLASS in 1 CARTON (25208-001-04) / 15 mL in 1 VIAL, GLASSMarketed from Oct 15, 2016 |
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)
- Aggrastat
- Generic name (nonproprietary)
- tirofiban
- Active ingredients
- Tirofiban hydrochloride — 3.75 mg/15mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Medicure International IncNDC labeler code 25208
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020912
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Platelet Aggregation (Physiologic effect)
- Identifiers
- Product ID 25208-001_6fae214d-f37d-49ff-b1bb-266584eb664fSPL ID 6fae214d-f37d-49ff-b1bb-266584eb664fSPL set ID fe0ced75-ccbf-4d2e-bd0d-b57e60ab913fRxCUI 1737466, 1737468, 1737471, 1737472, 1813035, 1813037UNII 6H925F8O5J
- 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
N425208000104followed by a unit qualifier and the quantityPackage 25208-0001-04. 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)
AGGRASTAT® 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). AGGRASTAT 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).
Excerpt only. Read the full label for complete information.
About NDC 25208-001
- What is NDC 25208-001?
- 25208-001 is the product NDC for Aggrastat (tirofiban), Tirofiban hydrochloride 3.75 mg/15mL injection, solution, listed with the FDA by Medicure International Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Aggrastat (Tirofiban).
- What is the active ingredient?
- Tirofiban hydrochloride.
- Who is the labeler?
- Medicure International Inc, NDC labeler code 25208. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Aggrastat?
- 3 other product NDCs are listed under this name. See all Aggrastat NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Aggrastat products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Aggrastattirofiban | Tirofiban hydrochloride 3.75 mg/15mL | Injection, SolutionIntravenous | Medicure International Inc | 25208-901 | 25208-0901-04 |
| Aggrastattirofiban | Tirofiban hydrochloride 5 mg/100mL | Injection, SolutionIntravenous | Medicure International Inc | 25208-002 | 25208-0002-0125208-0002-02 |
| Aggrastattirofiban | Tirofiban hydrochloride 5 mg/100mL | Injection, SolutionIntravenous | Medicure International Inc | 25208-902 | 25208-0902-0125208-0902-02 |
Other NDCs under NDA 020912
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 |
|---|---|---|---|---|
| Aggrastattirofiban | Tirofiban hydrochloride 3.75 mg/15mL | Injection, SolutionIntravenous | Medicure International Inc | 25208-901 |