Bivalirudin NDC 55111-652

NDC codes

FDA NDC Directory

Product NDC (as listed)55111-652Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55111-0652Add 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
55111-652-37	55111065237	10 VIAL, SINGLE-DOSE in 1 CARTON (55111-652-37) / 1 INJECTION in 1 VIAL, SINGLE-DOSE (55111-652-07)Marketed from May 31, 2017

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
Route: Intracavernous
Labeler: Dr. Reddy's Laboratories Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201577
Marketing start: May 31, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Thrombin Inhibitors (Mechanism)
Identifiers: Product ID 55111-652_2c95d0ae-12a5-4981-d4cf-99e26a7f5a69SPL ID 2c95d0ae-12a5-4981-d4cf-99e26a7f5a69SPL set ID 19beb2ae-6064-3c24-fe50-0cee86896979RxCUI 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.

NDC on a medical claim

N455111065237 followed by a unit qualifier and the quantity

Package 55111-0652-37. 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 Jul 16, 2019.

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.

Full label on DailyMed (opens in a new tab)