Amiodarone Hydrochloride NDC 67457-153

NDC codes

FDA NDC Directory

Product NDC (as listed)67457-153Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67457-0153Add 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
67457-153-03	67457015303	10 VIAL, GLASS in 1 CARTON (67457-153-03) / 3 mL in 1 VIAL, GLASS (67457-153-00)Marketed from Oct 15, 2002
67457-153-09	67457015309	10 VIAL, GLASS in 1 CARTON (67457-153-09) / 9 mL in 1 VIAL, GLASS (67457-153-99)Marketed from Jan 5, 2004
67457-153-18	67457015318	1 VIAL, GLASS in 1 CARTON (67457-153-18) / 18 mL in 1 VIAL, GLASSMarketed from Nov 14, 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: Mylan Institutional LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076217
Marketing start: Oct 14, 2002
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 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers: Product ID 67457-153_bd9c578c-322f-41fc-936d-bf9b551a2782SPL ID bd9c578c-322f-41fc-936d-bf9b551a2782SPL set ID fcc8658c-761a-443f-8c32-1499d86028ecRxCUI 1663224, 1663244, 1663248UNII 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 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

N467457015303 followed by a unit qualifier and the quantity

Package 67457-0153-03. 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 Jul 15, 2020.

Indications (excerpt from the label)

Amiodarone hydrochloride 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 s…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076217

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

FDA NDC Directory listings under ANDA 076217
Product	Strength	Form · route	Labeler	Product NDC
Amiodarone Hydrochloride	Amiodarone hydrochloride 50 mg/mL	Injection, SolutionIntravenous	Mylan Institutional LLC	72078-046
Amiodarone Hydrochloride	Amiodarone hydrochloride 50 mg/mL	Injection, SolutionIntravenous	Medical Purchasing Solutions, LLC	71872-7163
Amiodarone Hydrochloride	Amiodarone hydrochloride 50 mg/mL	Injection, SolutionIntravenous	ProPharma Distribution	84549-153
Amiodarone Hydrochloride	Amiodarone hydrochloride 50 mg/mL	Injection, SolutionIntravenous	HF Acquisition Co LLC, DBA HealthFirst	51662-1358