Dofetilide
- Product NDC
- 42794-045
- 11-digit product format
- 427940045
- Labeler code
- 42794
- Product ID
- 42794-045_f1f1f93d-aee6-246f-e053-2a95a90a9eee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dofetilide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Sigmapharm Laboratories, LLC
- Application
- ANDA207746
- Marketing category
- ANDA
- Marketing start
- 2018-06-11
- Substance
- DOFETILIDE
- Active strength
- 250 ug/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 | 250 ug/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 |
|---|
| 42794-045-10 | Dofetilide | 60 in 1 BOTTLE, PLASTIC | CAPSULE | 60 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42794-045 | DOFETILIDE CAPSULE [SIGMAPHARM LABORATORIES, LLC] | 7 | Current NDC, Legacy NDC, 1 package rows | 20230111_0cb2ef7d-e35b-483b-9985-cfef99d7b96f.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 |
|---|
| 42794-045-10 | 42794004510 | 60 CAPSULE in 1 BOTTLE, PLASTIC (42794-045-10) | 60 capsule | 2018-06-11 | 0000-00-00 | No | No | Current |