Prescription drug · NDA
Nexterone (Amiodarone Hci) NDC 51662-1481
Amiodarone hydrochloride 1.8 mg/mL · Injection, Solution · Intravenous · HF Acquisition Co LLC, DBA HealthFirst
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51662-1481-1 | 5166214810151662148101 | 1 BAG in 1 CARTON (51662-1481-1) / 200 mL in 1 BAGMarketed from Jan 29, 2020 |
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)
- Nexterone (Amiodarone Hci)
- Generic name (nonproprietary)
- nexterone (amiodarone hci)
- Active ingredients
- Amiodarone hydrochloride — 1.8 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- HF Acquisition Co LLC, DBA HealthFirstNDC labeler code 51662
- 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 51662-1481_11c3bf02-6616-9353-e063-6394a90af9cdSPL ID 11c3bf02-6616-9353-e063-6394a90af9cdSPL set ID 9d4d66f7-fa14-e832-e053-2a95a90a8b62RxCUI 849876, 1046406UNII 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
N451662148101followed by a unit qualifier and the quantityPackage 51662-1481-01. 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)
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 also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication. During or after treatment with NEXTERONE, patients may be transferred to oral amiodarone therapy [see Dosage and Administration ( 2 )]. Use NEXTERONE for acute treatment until the patient's ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but NEXTERONE may be safely administered for longer…
Excerpt only. Read the full label for complete information.
About NDC 51662-1481
- What is NDC 51662-1481?
- 51662-1481 is the product NDC for Nexterone (Amiodarone Hci), Amiodarone hydrochloride 1.8 mg/mL injection, solution, listed with the FDA by HF Acquisition Co LLC, DBA HealthFirst. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nexterone (Amiodarone Hci).
- What is the active ingredient?
- Amiodarone hydrochloride.
- Who is the labeler?
- HF Acquisition Co LLC, DBA HealthFirst, NDC labeler code 51662. 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 (Amiodarone Hci)?
- 1 other product NDC are listed under this name. See all Nexterone (Amiodarone Hci) NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nexterone (Amiodarone Hci) products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nexterone (Amiodarone Hci) | Amiodarone hydrochloride 1.5 mg/mL | Injection, SolutionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1480 | 51662-1480-01 |
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 |
| Nexteroneamiodarone hydrochloride | Amiodarone hydrochloride 1.8 mg/mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 43066-360 |
| Nexterone (Amiodarone Hci) | Amiodarone hydrochloride 1.5 mg/mL | Injection, SolutionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1480 |