Dofetilide
- Product NDC
- 76282-755
- 11-digit product format
- 762820755
- Labeler code
- 76282
- Product ID
- 76282-755_19f2a722-24ef-44f2-90e6-ec8df457baf6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dofetilide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- EXELAN PHARMACEUTICALS, INC.
- Application
- ANDA212750
- Marketing category
- ANDA
- Marketing start
- 2024-11-01
- Substance
- DOFETILIDE
- Active strength
- .125 mg/1
- Pharmacologic classes
- Antiarrhythmic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dofetilide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DOFETILIDE | .125 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R4Z9X1N2ND |
| Rxcui | 310003, 310004, 310005 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76282-755-60 | Dofetilide | 60 in 1 BOTTLE | CAPSULE | 60 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76282-755 | DOFETILIDE CAPSULE [EXELAN PHARMACEUTICALS, INC.] | 2 | Current NDC, 1 package rows | 20241115_41ccbb23-ae03-44bd-b438-0b0a8388d56b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76282-755-60 | 76282075560 | 60 CAPSULE in 1 BOTTLE (76282-755-60) | 60 capsule | 2024-11-01 | No | No | Current |