Argatroban NDC 83301-0062

NDC codes

FDA NDC Directory

Product NDC (as listed)83301-0062Labeler and product segments. Claims need a package NDC.

Product NDC at billing width83301-0062Add 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
83301-0062-1	83301006201	1 VIAL, SINGLE-DOSE in 1 CARTON (83301-0062-1) / 50 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 10, 2026

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: Mullan Pharmaceutical Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217848
Marketing start: Mar 10, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Thrombin Inhibitors (Mechanism)
Identifiers: Product ID 83301-0062_5454d4f3-2931-ab28-e063-6394a90a8bf3SPL ID 5454d4f3-2931-ab28-e063-6394a90a8bf3SPL set ID 50e21062-f021-40f2-ad11-896f46378a15RxCUI 1804735UNII IY90U61Z3SUPC 0383301006217
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

N483301006201 followed by a unit qualifier and the quantity

Package 83301-0062-01. 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 Jun 15, 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 adult 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 217848

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

FDA NDC Directory listings under ANDA 217848
Product	Strength	Form · route	Labeler	Product NDC
Argatroban	Argatroban 50 mg/50mL	InjectionIntravenous	Mullan Pharmaceutical Inc.	83301-0500
Argatroban	Argatroban 50 mg/50mL	Injection, SolutionIntravenous	Gland Pharma Limited	68083-568