Prescription drug · ANDA
amiodarone hydrochloride NDC 68382-227
Amiodarone hydrochloride 200 mg/1 · Tablet · Oral · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68382-227-05 | 68382022705 | 500 TABLET in 1 BOTTLE (68382-227-05)Marketed from Aug 10, 2009 | |
| 68382-227-06 | 68382022706 | 30 TABLET in 1 BOTTLE (68382-227-06)Marketed from Aug 10, 2009 | |
| 68382-227-10 | 68382022710 | 1000 TABLET in 1 BOTTLE (68382-227-10)Marketed from Aug 10, 2009 | |
| 68382-227-14 | 68382022714 | 60 TABLET in 1 BOTTLE (68382-227-14)Marketed from Aug 10, 2009 | |
| 68382-227-77 | 68382022777 | 100 BLISTER PACK in 1 CARTON (68382-227-77) / 1 TABLET in 1 BLISTER PACK (68382-227-30)Marketed from Aug 10, 2009 |
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 — 200 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079029
- 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 68382-227_b3f11ad6-9f3b-4054-9c51-3d2614c1002eSPL ID b3f11ad6-9f3b-4054-9c51-3d2614c1002eSPL set ID b41cbcb5-9c5d-4e45-a4f2-952df5f22c00RxCUI 833528, 834348, 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
N468382022705followed by a unit qualifier and the quantityPackage 68382-0227-05. 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 tablet 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 079029
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 100 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-297 |
| amiodarone hydrochloride | Amiodarone hydrochloride 400 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-298 |
| amiodarone hydrochloride | Amiodarone hydrochloride 200 mg/1 | TabletOral | Safecor Health LLC | 48433-154 |
| Amiodarone hydrochloride | Amiodarone hydrochloride 200 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-631 |
| Amiodarone hydrochloride | Amiodarone hydrochloride 100 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-840 |
| Amiodarone hydrochloride | Amiodarone hydrochloride 400 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-841 |