Dofetilide is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Sigmapharm Laboratories, Llc. The primary component is Dofetilide.
| Product ID | 42794-046_6c45d21b-da17-2ee4-e053-2a91aa0a1881 |
| NDC | 42794-046 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Dofetilide |
| Generic Name | Dofetilide |
| Dosage Form | Capsule |
| Route of Administration | ORAL |
| Marketing Start Date | 2018-06-11 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA207746 |
| Labeler Name | Sigmapharm Laboratories, LLC |
| Substance Name | DOFETILIDE |
| Active Ingredient Strength | 500 ug/1 |
| Pharm Classes | Antiarrhythmic [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2018-06-11 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA207746 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2018-06-11 |
| Ingredient | Strength |
|---|---|
| DOFETILIDE | 500 ug/1 |
| SPL SET ID: | 0cb2ef7d-e35b-483b-9985-cfef99d7b96f |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0904-6681 | Dofetilide | Dofetilide |
| 0904-6682 | Dofetilide | Dofetilide |
| 0904-6683 | Dofetilide | Dofetilide |
| 16714-840 | Dofetilide | Dofetilide |
| 16714-841 | Dofetilide | Dofetilide |
| 16714-842 | Dofetilide | Dofetilide |
| 16729-490 | Dofetilide | Dofetilide |
| 16729-491 | Dofetilide | Dofetilide |
| 16729-492 | Dofetilide | Dofetilide |
| 42291-411 | Dofetilide | Dofetilide |
| 42291-412 | Dofetilide | Dofetilide |
| 42291-413 | Dofetilide | Dofetilide |
| 69452-132 | Dofetilide | Dofetilide |
| 69452-133 | Dofetilide | Dofetilide |
| 69452-131 | Dofetilide | Dofetilide |
| 42794-045 | Dofetilide | Dofetilide |
| 42794-044 | Dofetilide | Dofetilide |
| 42794-046 | Dofetilide | Dofetilide |
| 47335-061 | DOFETILIDE | DOFETILIDE |
| 47335-062 | DOFETILIDE | DOFETILIDE |
| 47335-063 | DOFETILIDE | DOFETILIDE |
| 51862-025 | Dofetilide | Dofetilide |
| 51862-125 | Dofetilide | Dofetilide |
| 51862-005 | Dofetilide | Dofetilide |
| 59762-0037 | Dofetilide | Dofetilide |
| 59762-0038 | Dofetilide | Dofetilide |
| 59651-119 | Dofetilide | Dofetilide |
| 59651-118 | Dofetilide | Dofetilide |
| 59651-120 | Dofetilide | Dofetilide |
| 59762-0039 | Dofetilide | Dofetilide |
| 71410-301 | Dofetilide | Dofetilide |
| 71410-300 | Dofetilide | Dofetilide |
| 71410-302 | Dofetilide | Dofetilide |
| 0069-5800 | Tikosyn | dofetilide |
| 0069-5810 | Tikosyn | dofetilide |
| 0069-5820 | Tikosyn | dofetilide |