Dofetilide NDC 16729-490

NDC codes

FDA NDC Directory

Product NDC (as listed)16729-490Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16729-0490Add 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
16729-490-12	16729049012	60 CAPSULE in 1 BOTTLE (16729-490-12)Marketed from Aug 20, 2020

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): Dofetilide
Generic name (nonproprietary): dofetilide
Active ingredients: Dofetilide — .125 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Accord Healthcare, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213338
Marketing start: Aug 20, 2020
Listing expires: Dec 31, 2026
Identifiers: Product ID 16729-490_40bca241-47f2-b7f0-e063-6294a90a1680SPL ID 40bca241-47f2-b7f0-e063-6294a90a1680SPL set ID 4c1a5a6d-bd69-473c-8caa-d0d242b7708dRxCUI 310003, 310004, 310005UNII 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

N416729049012 followed by a unit qualifier and the quantity

Package 16729-0490-12. 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 Oct 9, 2025. 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 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 in some …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 213338

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

FDA NDC Directory listings under ANDA 213338
Product	Strength	Form · route	Labeler	Product NDC
Dofetilide	Dofetilide .5 mg/1	CapsuleOral	Accord Healthcare, Inc.	16729-492
Dofetilide	Dofetilide .25 mg/1	CapsuleOral	Accord Healthcare, Inc.	16729-491