Prescription drug · ANDA
Argatroban NDC 70121-1037
Argatroban 100 mg/mL · Injection, Solution · Intravenous · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70121-1037-1 | 70121103701 | 1 VIAL, GLASS in 1 CARTON (70121-1037-1) / 2.5 mL in 1 VIAL, GLASSMarketed from Jan 26, 2018 |
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 — 100 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Amneal Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206698
- Marketing start
- Listing expires
- Other FDA classes
- Thrombin Inhibitors (Mechanism)
- Identifiers
- Product ID 70121-1037_f7911ddf-f082-4900-9504-d45cc15861c0SPL ID f7911ddf-f082-4900-9504-d45cc15861c0SPL set ID dedef330-555a-46b7-b1d6-0838b4cd9651RxCUI 308351UNII IY90U61Z3SUPC 0370121103714
- 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
N470121103701followed by a unit qualifier and the quantityPackage 70121-1037-01. 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 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.