Prescription drug · NDA
Nexterone (Amiodarone hydrochloride) NDC 43066-360
Amiodarone hydrochloride 1.8 mg/mL · Injection, Solution · Intravenous · Baxter Healthcare Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43066-360-20 | 4306603602043066036020 | 200 mL in 1 BAG (43066-360-20)Marketed from Nov 16, 2010 |
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)
- Nexterone
- Generic name (nonproprietary)
- amiodarone hydrochloride
- Active ingredients
- Amiodarone hydrochloride — 1.8 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Baxter Healthcare CorporationNDC labeler code 43066
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022325
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 1A2 Inhibitors (Mechanism)Cytochrome P450 2C9 Inhibitors (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 43066-360_86598704-4a32-4696-b2c2-2861e28db76aSPL ID 86598704-4a32-4696-b2c2-2861e28db76aSPL set ID e9108958-b8d7-4fba-87c3-9a32990de551RxCUI 849876, 1046406, 1046408, 1046410UNII 976728SY6Z
- Pharmacologic class
- Antiarrhythmic
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
N443066036020followed by a unit qualifier and the quantityPackage 43066-0360-20. 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)
NEXTERONE is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. NEXTERONE is an antiarrhythmic agent indicated for treatment and prophylaxis of ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. (1)
Excerpt only. Read the full label for complete information.
About NDC 43066-360
- What is NDC 43066-360?
- 43066-360 is the product NDC for Nexterone (amiodarone hydrochloride), Amiodarone hydrochloride 1.8 mg/mL injection, solution, listed with the FDA by Baxter Healthcare Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nexterone (Amiodarone hydrochloride).
- What is the active ingredient?
- Amiodarone hydrochloride.
- Who is the labeler?
- Baxter Healthcare Corporation, NDC labeler code 43066. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nexterone?
- 1 other product NDC are listed under this name. See all Nexterone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nexterone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nexteroneamiodarone hydrochloride | Amiodarone hydrochloride 1.5 mg/mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 43066-150 | 43066-0150-10 |
Other NDCs under NDA 022325
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 |
|---|---|---|---|---|
| Nexteroneamiodarone hydrochloride | Amiodarone hydrochloride 1.5 mg/mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 43066-150 |
| Nexterone (Amiodarone Hci) | Amiodarone hydrochloride 1.5 mg/mL | Injection, SolutionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1480 |
| Nexterone (Amiodarone Hci) | Amiodarone hydrochloride 1.8 mg/mL | Injection, SolutionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1481 |