Prescription drug · NDA
Bivalirudin NDC 70511-142
Bivalirudin 250 mg/1 · Injection, Solution · Intravenous · MAIA Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70511-142-50 | 7051101425070511014250 | 1 VIAL, SINGLE-DOSE in 1 CARTON (70511-142-50) / 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSEMarketed from May 27, 2024 | |
| 70511-142-84 | 7051101428470511014284 | 10 VIAL, SINGLE-DOSE in 1 CARTON (70511-142-84) / 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSEMarketed from May 27, 2024 |
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, Solution
- Route
- Intravenous
- Labeler
- MAIA Pharmaceuticals, Inc.NDC labeler code 70511
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 211215
- Marketing start
- Listing expires
- Other FDA classes
- Thrombin Inhibitors (Mechanism)
- Identifiers
- Product ID 70511-142_c727199d-f4cd-4658-8fdf-568590befaceSPL ID c727199d-f4cd-4658-8fdf-568590befaceSPL set ID c727199d-f4cd-4658-8fdf-568590befaceRxCUI 1997015UNII 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
N470511014250followed by a unit qualifier and the quantityPackage 70511-0142-50. 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 Injection is indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI), including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome. Bivalirudin 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 and heparin-induced thrombocytopenia and thrombosis syndrome.
Excerpt only. Read the full label for complete information.
About NDC 70511-142
- What is NDC 70511-142?
- 70511-142 is the product NDC for Bivalirudin, Bivalirudin 250 mg/1 injection, solution, listed with the FDA by MAIA Pharmaceuticals, Inc.. It has 2 package NDCs, 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?
- MAIA Pharmaceuticals, Inc., NDC labeler code 70511. 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, 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 |
| Bivalirudin | Bivalirudin 250 mg/1 | InjectionIntracavernous | Dr. Reddy's Laboratories Limited | 55111-652 | 55111-0652-37 |
Other NDCs under NDA 211215
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, SolutionIntravenous | Par Health USA, LLC | 42023-622 |