Dofetilide
- Product NDC
- 59651-120
- 11-digit product format
- 596510120
- Labeler code
- 59651
- Product ID
- 59651-120_1e91567e-437f-4695-8cc6-3e7a8fcb1606
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dofetilide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA210740
- Marketing category
- ANDA
- Marketing start
- 2019-01-22
- Substance
- DOFETILIDE
- Active strength
- .5 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 | .5 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 |
|---|
| 59651-120-05 | Dofetilide | 500 in 1 BOTTLE | CAPSULE | 500 | | 5 |
| 59651-120-60 | Dofetilide | 60 in 1 BOTTLE | CAPSULE | 60 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-120 | DOFETILIDE CAPSULE [AUROBINDO PHARMA LIMITED] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240121_85f2b35c-31d5-4161-b342-c781d23945a5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 59651-120-05 | 59651012005 | 500 CAPSULE in 1 BOTTLE (59651-120-05) | 500 capsule | 2019-01-22 | 0000-00-00 | No | No | Current |
| 59651-120-60 | 59651012060 | 60 CAPSULE in 1 BOTTLE (59651-120-60) | 60 capsule | 2019-01-22 | 0000-00-00 | No | No | Current |