Prescription drug · ANDA
Bivalirudin NDC 63323-562
Bivalirudin 250 mg/1 · Injection, Powder, Lyophilized, For solution · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-562-10 | 6332305621063323056210 | 10 VIAL, SINGLE-USE in 1 CARTON (63323-562-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USEMarketed from Oct 28, 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)
- Bivalirudin
- Generic name (nonproprietary)
- bivalirudin
- Active ingredients
- Bivalirudin — 250 mg/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090189
- Marketing start
- Listing expires
- Other FDA classes
- Thrombin Inhibitors (Mechanism)
- Identifiers
- Product ID 63323-562_2f51e657-4541-4458-8020-5063efc51eb7SPL ID 2f51e657-4541-4458-8020-5063efc51eb7SPL set ID af943fa0-ab0f-4b62-9ff0-54ee24cdb772RxCUI 308769UNII TN9BEX005GUPC 0363323562014
- 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
N463323056210followed by a unit qualifier and the quantityPackage 63323-0562-10. 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.
About NDC 63323-562
- What is NDC 63323-562?
- 63323-562 is the product NDC for Bivalirudin, Bivalirudin 250 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bivalirudin.
- What is the active ingredient?
- Bivalirudin.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Bivalirudin?
- 12 other product NDCs are listed under this name. See all Bivalirudin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Bivalirudin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Bivalirudin | Bivalirudin 250 mg/1 | Injection, SolutionIntravenous | MAIA Pharmaceuticals, Inc. | 70511-142 | 70511-0142-5070511-0142-84 |
| Bivalirudin | Bivalirudin 250 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous | Avenacy, LLC | 83634-400 | 83634-0400-10 |
| Bivalirudin | Bivalirudin 250 mg/1 | Injection, SolutionIntravenous | Par Health USA, LLC | 42023-622 | 42023-0622-0142023-0622-10 |
| bivalirudin | Bivalirudin 250 mg/1 | Injection, Powder, Lyophilized, For suspensionIntravenous | Slate Run Pharmaceuticals, LLC | 70436-025 | 70436-0025-8070436-0025-82 |
| bivalirudin | Bivalirudin 250 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous | Civica, Inc. | 72572-035 | 72572-0035-10 |
| Bivalirudin | Bivalirudin 250 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous | Hainan Shuangcheng Pharmaceuticals Co., Ltd. | 52958-034 | 52958-0034-01 |
| Bivalirudin | Bivalirudin 250 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Accord Healthcare, Inc. | 16729-275 | 16729-0275-67 |
| Bivalirudin | Bivalirudin 250 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous | Eugia US LLC | 55150-210 | 55150-0210-10 |
| Bivalirudin | Bivalirudin 250 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Meitheal Pharmaceuticals Inc. | 71288-427 | 71288-0427-11 |
| Bivalirudin | Bivalirudin 250 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Mylan Institutional LLC | 67457-256 | 67457-0256-10 |