Prescription drug · NDA AUTHORIZED GENERIC
bivalirudin NDC 72572-035
Bivalirudin 250 mg/1 · Injection, Powder, Lyophilized, For solution · Intravenous · Civica, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72572-035-10 | 7257200351072572003510 | 10 VIAL, SINGLE-USE in 1 CARTON (72572-035-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (72572-035-01)Marketed from Dec 21, 2020 |
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
- Civica, Inc.NDC labeler code 72572
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 020873
- Marketing start
- Listing expires
- Other FDA classes
- Thrombin Inhibitors (Mechanism)
- Identifiers
- Product ID 72572-035_53431803-dc0b-42dc-8766-e17c3dbdf4eaSPL ID 53431803-dc0b-42dc-8766-e17c3dbdf4eaSPL set ID 19a4afc5-151d-4d3c-bfef-48aa8797d695RxCUI 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
N472572003510followed by a unit qualifier and the quantityPackage 72572-0035-10. 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 72572-035
- What is NDC 72572-035?
- 72572-035 is the product NDC for bivalirudin, Bivalirudin 250 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by Civica, Inc.. 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?
- Civica, Inc., NDC labeler code 72572. 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 | 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 |
| Bivalirudin | Bivalirudin 250 mg/1 | InjectionIntracavernous | Dr. Reddy's Laboratories Limited | 55111-652 | 55111-0652-37 |
Other NDCs under NDA 020873
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 |
|---|---|---|---|---|
| bivalirudin | Bivalirudin 250 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous | Sandoz Inc | 0781-3158 |