Dofetilide
- Product NDC
- 0904-7524
- 11-digit product format
- 009047524
- Labeler code
- 0904
- Product ID
- 0904-7524_fa04423d-af73-45d4-bfba-d57d39a2e0b4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dofetilide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA207058
- Marketing category
- ANDA
- Marketing start
- 2024-10-17
- Substance
- DOFETILIDE
- Active strength
- .5 mg/1
- Pharmacologic classes
- Antiarrhythmic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dofetilide
- Listing expiration
- 2027-12-31
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 |
|---|
| 0904-7524-08 | Dofetilide | 40 in 1 CARTON | CAPSULE | 40 | | 3 |
| 0904-7524-08 | Dofetilide | 1 in 1 BLISTER PACK | CAPSULE | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7524 | DOFETILIDE CAPSULE [MAJOR PHARMACEUTICALS] | 1 | Current NDC, 2 package rows | 20241020_26de5f8c-8cec-46f6-a468-69451758a278.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 |
|---|
| 0904-7524-08 | 00904752408 | 40 BLISTER PACK in 1 CARTON (0904-7524-08) / 1 CAPSULE in 1 BLISTER PACK | 40 blister pack | 2024-10-17 | No | No | Historical |