Prescription drug · ANDA
Bivalirudin NDC 71288-427
Bivalirudin 250 mg/5mL · Injection, Powder, Lyophilized, For solution · Intravenous · Meitheal Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71288-427-11 | 71288042711 | 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-427-11) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-427-10)Marketed from Jul 16, 2018 |
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)
- Bivalirudin
- Generic name (nonproprietary)
- bivalirudin
- Active ingredients
- Bivalirudin — 250 mg/5mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091602
- Marketing start
- Listing expires
- Other FDA classes
- Thrombin Inhibitors (Mechanism)
- Identifiers
- Product ID 71288-427_2b20b742-4bab-4e5b-9d1b-9a7ca9e0daf7SPL ID 2b20b742-4bab-4e5b-9d1b-9a7ca9e0daf7SPL set ID 4119b710-ef30-4e3e-b99a-38e42b4b3fcaRxCUI 308769UNII TN9BEX005G
- Pharmacologic class
- Anti-coagulant; Direct Thrombin 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
N471288042711followed by a unit qualifier and the quantityPackage 71288-0427-11. 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)
Bivalirudin for Injection is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome. Bivalirudin for Injection is a direct thrombin inhibitor indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis syndrome (HITTS). ( 1 )
Excerpt only. Read the full label for complete information.