Dofetilide
- Product NDC
- 69452-133
- 11-digit product format
- 694520133
- Labeler code
- 69452
- Product ID
- 69452-133_f7811d48-6a19-d784-e053-6394a90aac27
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dofetilide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bionpharma Inc.
- Application
- ANDA208625
- Marketing category
- ANDA
- Marketing start
- 2018-04-11
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69452-133-17 | 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 |
|---|
| 69452-133 | DOFETILIDE CAPSULE [BIONPHARMA INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20230323_0e60aa4b-72c2-4ef4-ab01-c9cf94240ff1.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 |
|---|
| 69452-133-17 | 69452013317 | 60 CAPSULE in 1 BOTTLE (69452-133-17) | 60 capsule | 2018-04-11 | 0000-00-00 | No | No | Current |