Dofetilide NDC 0904-7524

NDC codes

FDA NDC Directory

Product NDC (as listed)0904-7524Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00904-7524Add 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
0904-7524-08	00904752408	40 BLISTER PACK in 1 CARTON (0904-7524-08) / 1 CAPSULE in 1 BLISTER PACKMarketed from Oct 17, 2024

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: Major Pharmaceuticals
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207058
Marketing start: Oct 17, 2024
Marketing end: Apr 30, 2027
Identifiers: Product ID 0904-7524_ee9fe799-9bd7-4caa-b629-0464d2417a68SPL ID ee9fe799-9bd7-4caa-b629-0464d2417a68SPL set ID 26de5f8c-8cec-46f6-a468-69451758a278RxCUI 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

N400904752408 followed by a unit qualifier and the quantity

Package 00904-7524-08. 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 31, 2026.

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 207058

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

FDA NDC Directory listings under ANDA 207058
Product	Strength	Form · route	Labeler	Product NDC
Dofetilide	Dofetilide .125 mg/1	CapsuleOral	Major Pharmaceuticals	0904-7522
Dofetilide	Dofetilide .25 mg/1	CapsuleOral	Major Pharmaceuticals	0904-7523
Dofetilide	Dofetilide .25 mg/1	CapsuleOral	Dr. Reddy's Labratories Inc.	75907-055
Dofetilide	Dofetilide .5 mg/1	CapsuleOral	Dr. Reddy's Labratories Inc.	75907-054
Dofetilide	Dofetilide .125 mg/1	CapsuleOral	Dr. Reddy's Labratories Inc.	75907-056