Dofetilide NDC 69452-133

NDC codes

FDA NDC Directory

Product NDC (as listed)69452-133Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69452-0133Add 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
69452-133-17	69452013317	60 CAPSULE in 1 BOTTLE (69452-133-17)Marketed from Apr 11, 2018

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 — .5 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Bionpharma Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208625
Marketing start: Apr 11, 2018
Listing expires: Dec 31, 2026
Identifiers: Product ID 69452-133_f7811d48-6a19-d784-e053-6394a90aac27SPL ID f7811d48-6a19-d784-e053-6394a90aac27SPL set ID 0e60aa4b-72c2-4ef4-ab01-c9cf94240ff1RxCUI 310003, 310004, 310005UNII R4Z9X1N2NDUPC 0369452133170, 0369452132173, 0369452131176
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

N469452013317 followed by a unit qualifier and the quantity

Package 69452-0133-17. 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 22, 2023. 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 208625

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

FDA NDC Directory listings under ANDA 208625
Product	Strength	Form · route	Labeler	Product NDC
Dofetilide	Dofetilide .125 mg/1	CapsuleOral	Bionpharma Inc.	69452-131
Dofetilide	Dofetilide .25 mg/1	CapsuleOral	Bionpharma Inc.	69452-132