Dofetilide NDC 70518-4738

NDC codes

FDA NDC Directory

Product NDC (as listed)70518-4738Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70518-4738Add 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
70518-4738-0	70518473800	100 POUCH in 1 BOX (70518-4738-0) / 1 CAPSULE in 1 POUCH (70518-4738-2)Marketed from Aug 26, 2026
70518-4738-1	70518473801	50 POUCH in 1 BOX (70518-4738-1) / 1 CAPSULE in 1 POUCH (70518-4738-2)Marketed from Aug 26, 2026

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): Dofetilide
Generic name (nonproprietary): dofetilide
Active ingredients: Dofetilide — .125 mg/1
Dosage form: Capsule
Route: Oral
Labeler: REMEDYREPACK INC.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213220
Marketing start: Aug 26, 2026
Listing expires: Dec 31, 2027
Identifiers: Product ID 70518-4738_59f77ab6-e52a-9506-e063-6294a90aa720SPL ID 59f77ab6-e52a-9506-e063-6294a90aa720SPL set ID cff8d66a-ed43-46dd-97de-3dd21a7f2572RxCUI 310003UNII R4Z9X1N2ND
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

N470518473800 followed by a unit qualifier and the quantity

Package 70518-4738-00. 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 Aug 26, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence) Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because dofetilide capsules can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected…

Excerpt only. Read the full label for complete information.

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