Prescription drug · NDA
Argatroban NDC 16729-430
Argatroban 1 mg/mL · Injection · Intravenous · Accord Healthcare Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16729-430-11 | 1672904301116729043011 | 1 VIAL, SINGLE-USE in 1 CARTON (16729-430-11) / 50 mL in 1 VIAL, SINGLE-USEMarketed from Oct 7, 2021 | |
| 16729-430-43 | 1672904304316729043043 | 10 VIAL, SINGLE-USE in 1 CARTON (16729-430-43) / 50 mL in 1 VIAL, SINGLE-USEMarketed from Oct 7, 2021 |
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 — 1 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Accord Healthcare Inc.NDC labeler code 16729
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 212035
- Marketing start
- Listing expires
- Other FDA classes
- Thrombin Inhibitors (Mechanism)
- Identifiers
- Product ID 16729-430_525900ef-aa6b-7f43-e063-6294a90a27deSPL ID 525900ef-aa6b-7f43-e063-6294a90a27deSPL set ID 46cdf9e6-839c-49c8-9ee1-c30cfdd9368dRxCUI 1804735UNII IY90U61Z3SUPC 0316729430111
- 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
N416729043011followed by a unit qualifier and the quantityPackage 16729-0430-11. 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 in Sodium Chloride injection 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 in Sodium Chloride Injection is indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT). 1.2 Percutaneous Coronary Intervention Argatroban in Sodium Chloride Injection is indicated as an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary …
Excerpt only. Read the full label for complete information.
About NDC 16729-430
- What is NDC 16729-430?
- 16729-430 is the product NDC for Argatroban, Argatroban 1 mg/mL injection, listed with the FDA by Accord Healthcare Inc.. It has 2 package NDCs, 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?
- Accord Healthcare Inc., NDC labeler code 16729. 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 50 mg/50mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-568 | 68083-0568-01 |
| 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 |