Argatroban NDC 65145-126

NDC codes

FDA NDC Directory

Product NDC (as listed)65145-126Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65145-0126Add 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
65145-126-01	65145012601	1 VIAL in 1 CARTON (65145-126-01) / 50 mL in 1 VIALMarketed from Apr 17, 2026

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): Argatroban
Generic name (nonproprietary): argatroban
Active ingredients: Argatroban — 50 mg/50mL
Dosage form: Injection
Route: Intravenous
Labeler: Caplin Steriles Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214235
Marketing start: Apr 17, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Thrombin Inhibitors (Mechanism)
Identifiers: Product ID 65145-126_b36d78fb-27ca-45cf-a980-335364fe53c0SPL ID b36d78fb-27ca-45cf-a980-335364fe53c0SPL set ID b5143563-ff45-433a-a9e2-f8b8340db1f5RxCUI 1804735UNII IY90U61Z3SUPC 0365145126016
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

N465145012601 followed by a unit qualifier and the quantity

Package 65145-0126-01. 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 Apr 17, 2026.

Indications (excerpt from the label)

Argatroban is a direct thrombin inhibitor indicated: For prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT). ( 1.1 ) As an anticoagulant in adults patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI). ( 1.2 ) 1.1 Heparin-Induced Thrombocytopenia Argatroban Injection is indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT). 1.2 Percutaneous Coronary Intervention Argatroban Injection is indicated as an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 214235

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

FDA NDC Directory listings under ANDA 214235
Product	Strength	Form · route	Labeler	Product NDC
Argatroban	Argatroban 1 mg/mL	Injection, SolutionIntravenous	Sagent Pharmaceuticals	25021-414
Argatroban	Argatroban 50 mg/50mL	InjectionIntravenous	Fresenius Kabi USA, LLC	65219-429