Prescription drug · ANDA
Argatroban NDC 83301-0062
Argatroban 50 mg/50mL · Injection · Intravenous · Mullan Pharmaceutical Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83301-0062-1 | 8330100620183301006201 | 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.NDC labeler code 83301
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217848
- Marketing start
- Listing expires
- 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.
- NDC on a medical claim
N483301006201followed by a unit qualifier and the quantityPackage 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 .
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.
About NDC 83301-0062
- What is NDC 83301-0062?
- 83301-0062 is the product NDC for Argatroban, Argatroban 50 mg/50mL injection, listed with the FDA by Mullan Pharmaceutical Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Argatroban.
- What is the active ingredient?
- Argatroban.
- Who is the labeler?
- Mullan Pharmaceutical Inc., NDC labeler code 83301. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Argatroban?
- 16 other product NDCs are listed under this name. See all Argatroban NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Argatroban products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Argatroban | Argatroban 50 mg/50mL | InjectionIntravenous | Caplin Steriles Limited | 65145-126 | 65145-0126-01 |
| Argatroban | Argatroban 50 mg/50mL | InjectionIntravenous | Mullan Pharmaceutical Inc. | 83301-0500 | 83301-0500-01 |
| Argatroban | Argatroban 50 mg/50mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-568 | 68083-0568-01 |
| Argatroban | Argatroban 1 mg/mL | InjectionIntravenous | Accord Healthcare Inc. | 16729-430 | 16729-0430-1116729-0430-43 |
| Argatroban | Argatroban 50 mg/50mL | InjectionIntravenous | Fresenius Kabi USA, LLC | 65219-429 | 65219-0429-50 |
| Argatroban | Argatroban 1 mg/mL | Injection, SolutionIntravenous | Sagent Pharmaceuticals | 25021-414 | 25021-0414-50 |
| Argatroban | Argatroban 50 mg/50mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9377 | 00143-9377-01 |
| Argatroban | Argatroban 50 mg/50mL | Injection, SolutionIntravenous | Eugia US LLC | 55150-241 | 55150-0241-0155150-0241-10 |
| Argatroban | Argatroban 100 mg/mL | Injection, SolutionIntravenous | Amneal Pharmaceuticals LLC | 70121-1037 | 70121-1037-01 |
| Argatroban | Argatroban 250 mg/2.5mL | Injection, SolutionIntravenous | Mylan Institutional LLC | 67457-212 | 67457-0212-02 |
Other NDCs under ANDA 217848
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 | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-568 |
| Argatroban | Argatroban 50 mg/50mL | InjectionIntravenous | Mullan Pharmaceutical Inc. | 83301-0500 |