Argatroban NDC 68083-568

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-568Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0568Add 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
68083-568-01	68083056801	1 VIAL in 1 CARTON (68083-568-01) / 50 mL in 1 VIALMarketed from Jul 31, 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): Argatroban
Generic name (nonproprietary): argatroban
Active ingredients: Argatroban — 50 mg/50mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Gland Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217848
Marketing start: Jul 31, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Thrombin Inhibitors (Mechanism)
Identifiers: Product ID 68083-568_aef05b20-ddc7-48bd-b0b9-8528d15afde9SPL ID aef05b20-ddc7-48bd-b0b9-8528d15afde9SPL set ID 270dbb59-e080-4a64-91d9-a68bed4bd2e5RxCUI 1804735UNII IY90U61Z3S
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

N468083056801 followed by a unit qualifier and the quantity

Package 68083-0568-01. 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 9, 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	InjectionIntravenous	Mullan Pharmaceutical Inc.	83301-0062