Prescription drug · ANDA
Argatroban NDC 68083-568
Argatroban 50 mg/50mL · Injection, Solution · Intravenous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-568-01 | 6808305680168083056801 | 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 LimitedNDC labeler code 68083
- 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 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.
- NDC on a medical claim
N468083056801followed by a unit qualifier and the quantityPackage 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 .
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 68083-568
- What is NDC 68083-568?
- 68083-568 is the product NDC for Argatroban, Argatroban 50 mg/50mL injection, solution, listed with the FDA by Gland Pharma Limited. 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?
- Gland Pharma Limited, NDC labeler code 68083. 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. | 83301-0062 | 83301-0062-01 |
| Argatroban | Argatroban 50 mg/50mL | InjectionIntravenous | Mullan Pharmaceutical Inc. | 83301-0500 | 83301-0500-01 |
| 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 | InjectionIntravenous | Mullan Pharmaceutical Inc. | 83301-0062 |
| Argatroban | Argatroban 50 mg/50mL | InjectionIntravenous | Mullan Pharmaceutical Inc. | 83301-0500 |