Prescription drug · ANDA
Dofetilide NDC 47335-061
Dofetilide .125 mg/1 · Capsule · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47335-061-79 | 4733500617947335006179 | 4 BLISTER PACK in 1 CARTON (47335-061-79) / 10 CAPSULE in 1 BLISTER PACK (47335-061-66)Marketed from Oct 11, 2018 | |
| 47335-061-86 | 4733500618647335006186 | 60 CAPSULE in 1 BOTTLE (47335-061-86)Marketed from Oct 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 — .125 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 47335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210466
- Marketing start
- Listing expires
- Identifiers
- Product ID 47335-061_3ea6a12b-26de-4858-aebe-4f8902cc560fSPL ID 3ea6a12b-26de-4858-aebe-4f8902cc560fSPL set ID e6caaf44-4a3e-46ef-85fa-f97f682fbdd6RxCUI 310003, 310004, 310005UNII R4Z9X1N2NDUPC 0347335062861, 0347335061864
- 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
N447335006179followed by a unit qualifier and the quantityPackage 47335-0061-79. 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 & 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 pa…
Excerpt only. Read the full label for complete information.
About NDC 47335-061
- What is NDC 47335-061?
- 47335-061 is the product NDC for Dofetilide, Dofetilide .125 mg/1 capsule, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dofetilide.
- What is the active ingredient?
- Dofetilide.
- Who is the labeler?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dofetilide?
- 31 other product NDCs are listed under this name. See all Dofetilide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dofetilide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dofetilide | Dofetilide .125 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4738 | 70518-4738-0070518-4738-01 |
| Dofetilide | Dofetilide .25 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4617 | 70518-4617-00 |
| Dofetilide | Dofetilide .125 mg/1 | CapsuleOral | EXELAN PHARMACEUTICALS, INC. | 76282-755 | 76282-0755-60 |
| Dofetilide | Dofetilide .25 mg/1 | CapsuleOral | EXELAN PHARMACEUTICALS, INC. | 76282-756 | 76282-0756-60 |
| Dofetilide | Dofetilide .5 mg/1 | CapsuleOral | EXELAN PHARMACEUTICALS, INC. | 76282-757 | 76282-0757-60 |
| Dofetilide | Dofetilide .125 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7522 | 00904-7522-08 |
| Dofetilide | Dofetilide .25 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7523 | 00904-7523-08 |
| Dofetilide | Dofetilide .5 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7524 | 00904-7524-08 |
| Dofetilide | Dofetilide .5 mg/1 | CapsuleOral | Dr. Reddy's Labratories Inc. | 75907-054 | 75907-0054-60 |
| Dofetilide | Dofetilide .25 mg/1 | CapsuleOral | Dr. Reddy's Labratories Inc. | 75907-055 | 75907-0055-60 |
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 .25 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 47335-062 |
| Dofetilide | Dofetilide .5 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 47335-063 |
| Dofetilide | Dofetilide .125 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-130 |
| Dofetilide | Dofetilide .25 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-131 |
| Dofetilide | Dofetilide .5 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-132 |