Prescription drug · ANDA
Dofetilide NDC 72603-132
Dofetilide .5 mg/1 · Capsule · Oral · NorthStar RxLLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72603-132-01 | 72603013201 | 60 CAPSULE in 1 BOTTLE (72603-132-01)Marketed from Feb 7, 2023 |
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
- NorthStar RxLLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210466
- Marketing start
- Listing expires
- Identifiers
- Product ID 72603-132_d9cc5e83-13c7-40a5-86d3-29216f7f55feSPL ID d9cc5e83-13c7-40a5-86d3-29216f7f55feSPL set ID 4552d82a-dd28-410c-9642-1af060832b47RxCUI 310003, 310004, 310005UNII R4Z9X1N2NDUPC 0372603130010, 0372603132014, 0372603131017
- 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
N472603013201followed by a unit qualifier and the quantityPackage 72603-0132-01. 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 . 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.
Other NDCs under ANDA 210466
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Dofetilide | Dofetilide .5 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 47335-063 |
| Dofetilide | Dofetilide .125 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 47335-061 |
| Dofetilide | Dofetilide .25 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 47335-062 |
| Dofetilide | Dofetilide .125 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-130 |
| Dofetilide | Dofetilide .25 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-131 |