DOFETILIDE
- Product NDC
- 47335-062
- 11-digit product format
- 473350062
- Labeler code
- 47335
- Product ID
- 47335-062_3ea6a12b-26de-4858-aebe-4f8902cc560f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DOFETILIDE
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA210466
- Marketing category
- ANDA
- Marketing start
- 2018-10-11
- Substance
- DOFETILIDE
- Active strength
- .25 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 | .25 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 |
|---|
| 47335-062-66 | DOFETILIDE | 10 in 1 BLISTER PACK | CAPSULE | 10 | | 7 |
| 47335-062-79 | DOFETILIDE | 4 in 1 CARTON | CAPSULE | 4 | | 7 |
| 47335-062-86 | DOFETILIDE | 60 in 1 BOTTLE | CAPSULE | 60 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47335-062 | DOFETILIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 7 | Current NDC, Legacy NDC, 3 package rows | 20231102_e6caaf44-4a3e-46ef-85fa-f97f682fbdd6.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 |
|---|
| 47335-062-66 | 47335006266 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 47335-062-79 | 47335006279 | 4 BLISTER PACK in 1 CARTON (47335-062-79) / 10 CAPSULE in 1 BLISTER PACK (47335-062-66) | 4 blister pack | 2018-10-11 | 0000-00-00 | No | No | Current |
| 47335-062-86 | 47335006286 | 60 CAPSULE in 1 BOTTLE (47335-062-86) | 60 capsule | 2018-10-11 | 0000-00-00 | No | No | Current |