Prescription drug · NDA
Tikosyn (Dofetilide) NDC 0069-5800
Dofetilide .125 mg/1 · Capsule · Oral · Pfizer Laboratories Div Pfizer Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0069-5800-60 | 00069580060 | 60 CAPSULE in 1 BOTTLE (0069-5800-60)Marketed from Oct 1, 1999 | |
| 0069-5800-61 | 00069580061 | 14 CAPSULE in 1 BOTTLE (0069-5800-61)Marketed from Oct 1, 1999 |
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)
- Tikosyn
- Generic name (nonproprietary)
- dofetilide
- Active ingredients
- Dofetilide — .125 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Pfizer Laboratories Div Pfizer IncNDC labeler code 0069
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020931
- Marketing start
- Listing expires
- Identifiers
- Product ID 0069-5800_0109bfef-980f-4bc8-a802-3d3c45587456SPL ID 0109bfef-980f-4bc8-a802-3d3c45587456SPL set ID 02438044-d6a3-49e9-a1ac-3aad21ef2c8cRxCUI 284404, 284405, 285016, 310003, 310004, 310005UNII R4Z9X1N2NDUPC 0300695810602, 0300695800603, 0300695820601
- 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
N400069580060followed by a unit qualifier and the quantityPackage 00069-5800-60. 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) TIKOSYN is 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 TIKOSYN 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 patients (see CL…
Excerpt only. Read the full label for complete information.
About NDC 0069-5800
- What is NDC 0069-5800?
- 0069-5800 is the product NDC for Tikosyn (dofetilide), Dofetilide .125 mg/1 capsule, listed with the FDA by Pfizer Laboratories Div Pfizer Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tikosyn (Dofetilide).
- What is the active ingredient?
- Dofetilide.
- Who is the labeler?
- Pfizer Laboratories Div Pfizer Inc, NDC labeler code 0069. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tikosyn?
- 2 other product NDCs are listed under this name. See all Tikosyn NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tikosyn products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tikosyndofetilide | Dofetilide .25 mg/1 | CapsuleOral | Pfizer Laboratories Div Pfizer Inc | 0069-5810 | 00069-5810-6000069-5810-61 |
| Tikosyndofetilide | Dofetilide .5 mg/1 | CapsuleOral | Pfizer Laboratories Div Pfizer Inc | 0069-5820 | 00069-5820-6000069-5820-61 |
Other NDCs under NDA 020931
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 |
|---|---|---|---|---|
| Tikosyndofetilide | Dofetilide .25 mg/1 | CapsuleOral | Pfizer Laboratories Div Pfizer Inc | 0069-5810 |
| Tikosyndofetilide | Dofetilide .5 mg/1 | CapsuleOral | Pfizer Laboratories Div Pfizer Inc | 0069-5820 |