Dofetilide
- Product NDC
- 16729-491
- 11-digit product format
- 167290491
- Labeler code
- 16729
- Product ID
- 16729-491_40bca241-47f2-b7f0-e063-6294a90a1680
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dofetilide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Accord Healthcare, Inc.
- Application
- ANDA213338
- Marketing category
- ANDA
- Marketing start
- 2020-08-20
- 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 |
|---|
| 16729-491-12 | Dofetilide | 60 in 1 BOTTLE | CAPSULE | 60 | | 7 |
| 16729-491-59 | Dofetilide | 180 in 1 BOTTLE | CAPSULE | 180 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-491 | DOFETILIDE CAPSULE [ACCORD HEALTHCARE, INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241122_4c1a5a6d-bd69-473c-8caa-d0d242b7708d.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 |
|---|
| 16729-491-12 | 16729049112 | 60 CAPSULE in 1 BOTTLE (16729-491-12) | 60 capsule | 2020-08-20 | 0000-00-00 | No | No | Current |
| 16729-491-59 | 16729049159 | 180 in 1 BOTTLE | | | | | | Historical |