Bivalirudin NDC 42023-622

NDC codes

FDA NDC Directory

Product NDC (as listed)42023-622Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42023-0622Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
42023-622-01	42023062201	1 VIAL, SINGLE-DOSE in 1 CARTON (42023-622-01) / 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSEMarketed from Jun 19, 2023
42023-622-10	42023062210	10 VIAL, SINGLE-DOSE in 1 CARTON (42023-622-10) / 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSEMarketed from Jun 19, 2023

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: Par Health USA, LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 211215
Marketing start: Jun 19, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Thrombin Inhibitors (Mechanism)
Identifiers: Product ID 42023-622_e7a51342-62b0-420f-ad3c-530e8d1409c1SPL ID e7a51342-62b0-420f-ad3c-530e8d1409c1SPL set ID 91cf9d00-29e0-4357-a184-f70026c47edbRxCUI 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.

How CPT relates to drug billing

NDC on a medical claim

N442023062201 followed by a unit qualifier and the quantity

Package 42023-0622-01. 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 Mar 1, 2024.

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. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 211215

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 211215
Product	Strength	Form · route	Labeler	Product NDC
Bivalirudin	Bivalirudin 250 mg/1	Injection, SolutionIntravenous	MAIA Pharmaceuticals, Inc.	70511-142