Prescription drug · ANDA
Amiodarone Hydrochloride NDC 55150-181
Amiodarone hydrochloride 450 mg/9mL · Injection, Solution · Intravenous · AuroMedics Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55150-181-09 | 55150018109 | 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-181-09) / 9 mL in 1 VIAL, SINGLE-DOSEMarketed from Oct 25, 2017 |
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)
- Amiodarone Hydrochloride
- Generic name (nonproprietary)
- amiodarone hydrochloride
- Active ingredients
- Amiodarone hydrochloride — 450 mg/9mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- AuroMedics Pharma LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204550
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 1A2 Inhibitors (Mechanism)Cytochrome P450 2C9 Inhibitors (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 55150-181_c2e4f552-4ed1-4c8c-b865-39596b79b1adSPL ID c2e4f552-4ed1-4c8c-b865-39596b79b1adSPL set ID 6cd870d7-6381-421a-89bc-bce5c9518219RxCUI 833532, 1663224, 1663244UNII 976728SY6ZUPC 0355150180035, 0355150182183, 0355150181094
- 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
N455150018109followed by a unit qualifier and the quantityPackage 55150-0181-09. 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)
Amiodarone hydrochloride injection 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. Amiodarone 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 amiodarone, patients may be transferred to oral amiodarone therapy [see Dosage and Administration (2) ] . Use amiodarone for acute treatment until the patient's ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but amiodarone may be s…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204550
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 |
|---|---|---|---|---|
| Amiodarone Hydrochloride | Amiodarone hydrochloride 150 mg/3mL | Injection, SolutionIntravenous | Medical Purchasing Solutions, LLC | 71872-7149 |
| Amiodarone Hydrochloride | Amiodarone hydrochloride 150 mg/3mL | Injection, SolutionIntravenous | AuroMedics Pharma LLC | 55150-180 |
| Amiodarone Hydrochloride | Amiodarone hydrochloride 900 mg/18mL | Injection, SolutionIntravenous | AuroMedics Pharma LLC | 55150-182 |