Dofetilide NDC 72205-039

NDC codes

FDA NDC Directory

Product NDC (as listed)72205-039Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72205-0039Add 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
72205-039-37	72205003937	4 BLISTER PACK in 1 CARTON (72205-039-37) / 10 CAPSULE in 1 BLISTER PACK (72205-039-11)Marketed from Jun 12, 2020
72205-039-60	72205003960	60 CAPSULE in 1 BOTTLE (72205-039-60)Marketed from Jun 12, 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: Novadoz Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213220
Marketing start: Jun 12, 2020
Listing expires: Dec 31, 2026
Identifiers: Product ID 72205-039_feb8626e-9d88-4a06-919f-f8169a69814bSPL ID feb8626e-9d88-4a06-919f-f8169a69814bSPL set ID b8323987-90fe-4e6c-a71c-76e3c501713cRxCUI 310003, 310004, 310005UNII R4Z9X1N2NDUPC 0372205039605, 0372205040601, 0372205041608
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

N472205003937 followed by a unit qualifier and the quantity

Package 72205-0039-37. 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 29, 2022. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 213220

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

FDA NDC Directory listings under ANDA 213220
Product	Strength	Form · route	Labeler	Product NDC
Dofetilide	Dofetilide .125 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4738
Dofetilide	Dofetilide .25 mg/1	CapsuleOral	Novadoz Pharmaceuticals LLC	72205-040
Dofetilide	Dofetilide .5 mg/1	CapsuleOral	Novadoz Pharmaceuticals LLC	72205-041
Dofetilide	Dofetilide .25 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4617