Prescription drug · NDA
Argatroban NDC 0143-9288
Argatroban 250 mg/2.5mL · Injection · Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9288-01 | 00143928801 | 1 VIAL in 1 CARTON (0143-9288-01) / 2.5 mL in 1 VIALMarketed from Jan 5, 2012 |
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)
- Argatroban
- Generic name (nonproprietary)
- argatroban
- Active ingredients
- Argatroban — 250 mg/2.5mL
- Dosage form
- Injection
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 203049
- Marketing start
- Listing expires
- Other FDA classes
- Thrombin Inhibitors (Mechanism)
- Identifiers
- Product ID 0143-9288_6dc32247-fa53-4948-a7fb-f7e71051a62aSPL ID 6dc32247-fa53-4948-a7fb-f7e71051a62aSPL set ID 79eec27d-ac63-4996-8b1a-c2cd52ad2b2cRxCUI 308351UNII 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.
- NDC on a medical claim
N400143928801followed by a unit qualifier and the quantityPackage 00143-9288-01. 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 .
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.
Other NDCs under NDA 203049
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Argatroban | Argatroban 50 mg/50mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9559 |
| Argatroban | Argatroban 250 mg/2.5mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9674 |
| Argatroban | Argatroban 50 mg/50mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9377 |