Dofetilide
- Product NDC
- 51862-005
- 11-digit product format
- 518620005
- Labeler code
- 51862
- Product ID
- 51862-005_35cc8a01-96fa-43ab-8429-72396c201edd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dofetilide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Mayne Pharma Inc.
- Application
- ANDA207058
- Marketing category
- ANDA
- Marketing start
- 2016-06-07
- Marketing end
- 0000-00-00
- Substance
- DOFETILIDE
- Active strength
- 1 mg/1
- Pharmacologic classes
- Antiarrhythmic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| cdc36b95-20ce-9079-16ec-f3cdb4dcf4fd | Product name | 9 | 20230112 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 51862-005-60 | 2024-10-02 | C162847 | 48780-1 | 1030e365-269e-111a-e063-dadaa90a10e2 | DOFETILIDE CAPSULES |
| 51862-005-60 | 2024-01-30 | C162847 | 48780-1 | 1030e365-269e-111a-e063-dadaa90a10e2 | DOFETILIDE CAPSULES |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51862-005-60 | EA - Each | 51862-005 | bef0e4b9-c480-4e23-8244-7bbabea02709 | 1 | 2016-07-19 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310003 | dofetilide 125 MCG Oral Capsule | PSN | 66c20086-5030-441e-842d-2eee0d1a2a3a | 5 |
| 310004 | dofetilide 250 MCG Oral Capsule | PSN | 66c20086-5030-441e-842d-2eee0d1a2a3a | 5 |
| 310005 | dofetilide 500 MCG Oral Capsule | PSN | 66c20086-5030-441e-842d-2eee0d1a2a3a | 5 |
| 310003 | dofetilide 0.125 MG Oral Capsule | SCD | 66c20086-5030-441e-842d-2eee0d1a2a3a | 5 |
| 310004 | dofetilide 0.25 MG Oral Capsule | SCD | 66c20086-5030-441e-842d-2eee0d1a2a3a | 5 |
| 310005 | dofetilide 0.5 MG Oral Capsule | SCD | 66c20086-5030-441e-842d-2eee0d1a2a3a | 5 |
| 310003 | dofetilide 125 MCG Oral Capsule | SY | 66c20086-5030-441e-842d-2eee0d1a2a3a | 5 |
| 310004 | dofetilide 250 MCG Oral Capsule | SY | 66c20086-5030-441e-842d-2eee0d1a2a3a | 5 |
| 310005 | dofetilide 500 MCG Oral Capsule | SY | 66c20086-5030-441e-842d-2eee0d1a2a3a | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 51862-005-60 | 51862000560 | 60 CAPSULE in 1 BOTTLE, PLASTIC (51862-005-60) | 60 capsule | 2016-06-07 | 0000-00-00 | No | No | Current |