Prescription drug · ANDA
Tirofiban hydrochloride (Tirofiban) NDC 68083-145
Tirofiban hydrochloride 12.5 mg/250mL · Injection, Solution · Intravenous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-145-01 | 6808301450168083014501 | 1 CONTAINER in 1 CARTON (68083-145-01) / 250 mL in 1 CONTAINERMarketed from Apr 15, 2021 |
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 hydrochloride
- Generic name (nonproprietary)
- tirofiban
- Active ingredients
- Tirofiban hydrochloride — 12.5 mg/250mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Gland Pharma LimitedNDC labeler code 68083
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206888
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Platelet Aggregation (Physiologic effect)
- Identifiers
- Product ID 68083-145_a206685a-4e0d-40a1-8f39-a4b2f660d7d7SPL ID a206685a-4e0d-40a1-8f39-a4b2f660d7d7SPL set ID fa3ac570-f9f6-474c-a920-bd0cf03045acRxCUI 1737471UNII 6H925F8O5JUPC 0368083145019
- 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
N468083014501followed by a unit qualifier and the quantityPackage 68083-0145-01. 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).
Excerpt only. Read the full label for complete information.
About NDC 68083-145
- What is NDC 68083-145?
- 68083-145 is the product NDC for Tirofiban hydrochloride (tirofiban), Tirofiban hydrochloride 12.5 mg/250mL injection, solution, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tirofiban hydrochloride (Tirofiban).
- What is the active ingredient?
- Tirofiban hydrochloride.
- Who is the labeler?
- Gland Pharma Limited, NDC labeler code 68083. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tirofiban hydrochloride?
- 3 other product NDCs are listed under this name. See all Tirofiban hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tirofiban hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tirofiban Hydrochloride | Tirofiban hydrochloride 50 ug/mL | Injection, SolutionIntravenous | Sagent Pharmaceuticals | 25021-417 | 25021-0417-84 |
| Tirofiban Hydrochloride | Tirofiban hydrochloride 50 ug/mL | InjectionIntravenous | Nexus Pharmaceuticals LLC | 14789-101 | 14789-0101-01 |
| Tirofiban Hydrochloride | Tirofiban hydrochloride 50 ug/mL | InjectionIntravenous | Nexus Pharmaceuticals LLC | 14789-102 | 14789-0102-0214789-0102-10 |
Other NDCs under ANDA 206888
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 Hydrochloride | Tirofiban hydrochloride 50 ug/mL | Injection, SolutionIntravenous | Sagent Pharmaceuticals | 25021-417 |