bivalirudin NDC 0781-3158

NDC codes

FDA NDC Directory

Product NDC (as listed)0781-3158Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00781-3158Add 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
0781-3158-95	00781315895	10 VIAL, SINGLE-USE in 1 CARTON (0781-3158-95) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (0781-3158-94)Marketed from Jun 15, 2015

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: Sandoz Inc
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 020873
Marketing start: Jun 15, 2015
Listing expires: Dec 31, 2027
Other FDA classes: Thrombin Inhibitors (Mechanism)
Identifiers: Product ID 0781-3158_6d393e10-b1f2-42b1-bc50-920309c144c6SPL ID 6d393e10-b1f2-42b1-bc50-920309c144c6SPL set ID ce56f806-7845-429d-a1ce-c2dbf79b22ebRxCUI 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.

How CPT relates to drug billing

NDC on a medical claim

N400781315895 followed by a unit qualifier and the quantity

Package 00781-3158-95. 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 Sep 30, 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)

Other NDCs under NDA 020873

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

FDA NDC Directory listings under NDA 020873
Product	Strength	Form · route	Labeler	Product NDC
bivalirudin	Bivalirudin 250 mg/1	Injection, Powder, Lyophilized, For solutionIntravenous	Civica, Inc.	72572-035