Prescription drug · ANDA
Amiodarone Hydrochloride NDC 0615-8258
Amiodarone hydrochloride 200 mg/1 · Tablet · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8258-05 | 00615825805 | 15 TABLET in 1 BLISTER PACK (0615-8258-05)Marketed from Mar 5, 2019 | |
| 0615-8258-39 | 00615825839 | 30 TABLET in 1 BLISTER PACK (0615-8258-39)Marketed from Mar 5, 2019 |
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 — 200 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204742
- 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 0615-8258_faf8768b-1bab-4a7d-87c2-b13ee31b1853SPL ID faf8768b-1bab-4a7d-87c2-b13ee31b1853SPL set ID d42293e9-07fa-41b4-a08b-2e388f5b1e13RxCUI 833528UNII 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
N400615825805followed by a unit qualifier and the quantityPackage 00615-8258-05. 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 are 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 is an antiarrhythmic indicated for: Recurrent ventricular fibrillation. ( 1 ) Recurrent hemodynamically unstable ventricular tachycardia. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0615-8258
- What is NDC 0615-8258?
- 0615-8258 is the product NDC for Amiodarone Hydrochloride, Amiodarone hydrochloride 200 mg/1 tablet, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Amiodarone Hydrochloride.
- What is the active ingredient?
- Amiodarone hydrochloride.
- Who is the labeler?
- NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Amiodarone Hydrochloride?
- 61 other product NDCs are listed under this name. See all Amiodarone Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Amiodarone Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| amiodarone hydrochloride | Amiodarone hydrochloride 200 mg/1 | TabletOral | Safecor Health LLC | 48433-154 | 48433-0154-20 |
| Amiodarone Hydrochloride | Amiodarone hydrochloride 200 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7576 | 00904-7576-61 |
| Amiodarone Hydrochloride | Amiodarone hydrochloride 50 mg/mL | Injection, SolutionIntravenous | Henry Schein, Inc. | 0404-9772 | 00404-9772-03 |
| Amiodarone Hydrochloride | Amiodarone hydrochloride 50 mg/mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 65219-643 | 65219-0643-03 |
| Amiodarone Hydrochloride | Amiodarone hydrochloride 50 mg/mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 65219-645 | 65219-0645-09 |
| Amiodarone Hydrochloride | Amiodarone hydrochloride 50 mg/mL | Injection, SolutionIntravenous | Slate Run Pharmaceuticals | 70436-232 | 70436-0232-5070436-0232-5270436-0232-62 |
| Amiodarone Hydrochloride | Amiodarone hydrochloride 50 mg/mL | Injection, SolutionIntravenous | Medical Purchasing Solutions, LLC. | 71872-7354 | 71872-7354-01 |
| Amiodarone Hydrochloride | Amiodarone hydrochloride 100 mg/1 | TabletOral | Dr. Reddy's Labratories Inc. | 75907-005 | 75907-0005-30 |
| Amiodarone Hydrochloride | Amiodarone hydrochloride 200 mg/1 | TabletOral | Dr. Reddy's Labratories Inc. | 75907-006 | 75907-0006-60 |
| Amiodarone Hydrochloride | Amiodarone hydrochloride 50 mg/mL | Injection, SolutionIntravenous | Mylan Institutional LLC | 72078-046 | 72078-0046-0972078-0046-18 |
Other NDCs under ANDA 204742
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 | A-S Medication Solutions | 50090-3015 |
| Amiodarone Hydrochloride | Amiodarone hydrochloride 200 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-8185 |
| Amiodarone Hydrochloride | Amiodarone hydrochloride 200 mg/1 | TabletOral | American Health Packaging | 60687-437 |
| Amiodarone Hydrochloride | Amiodarone hydrochloride 200 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-732 |
| Amiodarone Hydrochloride | Amiodarone hydrochloride 200 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1939 |