Prescription drug · ANDA
amiodarone hydrochloride NDC 48433-154
Amiodarone hydrochloride 200 mg/1 · Tablet · Oral · Safecor Health LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 48433-154-20 | 48433015420 | 100 BLISTER PACK in 1 CARTON (48433-154-20) / 1 TABLET in 1 BLISTER PACK (48433-154-01)Marketed from Jun 1, 2026 |
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
- Labeler
- Safecor Health LLC
- 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 3A Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 48433-154_544f49d5-053a-73e8-e063-6394a90ada25SPL ID 544f49d5-053a-73e8-e063-6394a90ada25SPL set ID f49d011f-5ca6-4f75-ba16-2099fe42f5aaRxCUI 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
N448433015420followed by a unit qualifier and the quantityPackage 48433-0154-20. 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 | 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 |
| amiodarone hydrochloride | Amiodarone hydrochloride 200 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-227 |