Amiodarone Hydrochloride NDC 55154-3365

NDC codes

FDA NDC Directory

Product NDC (as listed)55154-3365Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55154-3365Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
55154-3365-0	55154336500	10 BLISTER PACK in 1 BAG (55154-3365-0) / 1 TABLET in 1 BLISTER PACKMarketed from Apr 20, 2020

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: Cardinal Health 107, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075424
Marketing start: Mar 30, 2001
Marketing end: Jan 31, 2027
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 55154-3365_7a34d62f-6b9b-44d2-aefa-8af7e388b13dSPL ID 7a34d62f-6b9b-44d2-aefa-8af7e388b13dSPL set ID 7bdc2236-3a1a-4210-a9fb-38f860227aa7RxCUI 833528UNII 976728SY6ZUPC 0055154336505
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

N455154336500 followed by a unit qualifier and the quantity

Package 55154-3365-00. 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 Apr 9, 2026. 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 tablets are an antiarrhythmic indicated for: • Recurrent ventricular fibrillation. ( 1 ) • Recurrent hemodynamically unstable ventricular tachycardia. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 075424

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 075424
Product	Strength	Form · route	Labeler	Product NDC
Amiodarone Hydrochloride	Amiodarone hydrochloride 200 mg/1	TabletOral	Bryant Ranch Prepack	71335-0881
Amiodarone Hydrochloride	Amiodarone hydrochloride 200 mg/1	TabletOral	Sun Pharmaceutical Industries, Inc.	51672-4025
Amiodarone Hydrochloride	Amiodarone hydrochloride 200 mg/1	TabletOral	Major Pharmaceuticals	0904-6993
Amiodarone Hydrochloride	Amiodarone hydrochloride 100 mg/1	TabletOral	Sun Pharmaceutical Industries, Inc.	51672-4055