Amiodarone Hydrochloride NDC 63323-616

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-616Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0616Add 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
63323-616-03	63323061603	25 VIAL, SINGLE-DOSE in 1 TRAY (63323-616-03) / 3 mL in 1 VIAL, SINGLE-DOSE (63323-616-01)Marketed from Jan 28, 2003
63323-616-09	63323061609	10 VIAL, SINGLE-DOSE in 1 TRAY (63323-616-09) / 9 mL in 1 VIAL, SINGLE-DOSE (63323-616-02)Marketed from Jan 28, 2003

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 — 50 mg/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Fresenius Kabi USA, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075761
Marketing start: Jan 28, 2003
Listing expires: Dec 31, 2026
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 63323-616_262974e7-d551-4123-adfa-2ee1c4fa6195SPL ID 262974e7-d551-4123-adfa-2ee1c4fa6195SPL set ID d8d04647-8e25-4127-8ecf-360ce1991c2fRxCUI 1663224, 1663244UNII 976728SY6ZUPC 0363323616021, 0363323616014
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N463323061603 followed by a unit qualifier and the quantity

Package 63323-0616-03. 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 Mar 31, 2025.

Indications (excerpt from the label)

Amiodarone injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. Amiodarone also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication. During or after treatment with amiodarone, patients may be transferred to oral amiodarone therapy [see Dosage and Administration ( 2 )] . Use amiodarone for acute treatment until the patient's ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but amiodarone may be safely adminis…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 075761

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

FDA NDC Directory listings under ANDA 075761
Product	Strength	Form · route	Labeler	Product NDC
Amiodarone Hydrochloride	Amiodarone hydrochloride 50 mg/mL	Injection, SolutionIntravenous	Fresenius Kabi USA, LLC	65219-645
Amiodarone Hydrochloride	Amiodarone hydrochloride 50 mg/mL	Injection, SolutionIntravenous	Fresenius Kabi USA, LLC	65219-643
Amiodarone Hci	Amiodarone hydrochloride 50 mg/mL	Injection, SolutionIntravenous	HF Acquisition Co LLC, DBA HealthFirst	51662-1363
Amiodarone Hydrochloride	Amiodarone hydrochloride 50 mg/mL	Injection, SolutionIntravenous	Medical Purchasing Solutions, LLC	71872-7034