Prescription drug · ANDA
Amiodarone Hydrochloride NDC 0615-8607
Amiodarone hydrochloride 100 mg/1 · Tablet · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8607-39 | 00615860739 | 30 TABLET in 1 BLISTER PACK (0615-8607-39)Marketed from Dec 17, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078578
- 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 0615-8607_95e3bff0-e303-4661-85e9-1d8ea93c5671SPL ID 95e3bff0-e303-4661-85e9-1d8ea93c5671SPL set ID 28cd0224-3569-4308-bd40-480bc4230503RxCUI 835956UNII 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400615860739followed by a unit qualifier and the quantityPackage 00615-8607-39. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Amiodarone Hydrochloride Tablets is indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated. Amiodarone Hydrochloride Tablets is an antiarrhythmic indicated for: Recurrent ventricular fibrillation. ( 1 ) Recurrent hemodynamically unstable ventricular tachycardia. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078578
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 200 mg/1 | TabletOral | Advagen Pharma Limited | 72888-039 |
| Amiodarone Hydrochloride | Amiodarone hydrochloride 200 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7576 |
| Amiodarone Hydrochloride | Amiodarone hydrochloride 100 mg/1 | TabletOral | Advagen Pharma Limited | 72888-060 |
| Amiodarone Hydrochloride | Amiodarone hydrochloride 400 mg/1 | TabletOral | Advagen Pharma Limited | 72888-061 |
| Amiodarone Hydrochloride | Amiodarone hydrochloride 200 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3439 |
| Amiodarone Hydrochloride | Amiodarone hydrochloride 200 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1985 |