NDC 16729-490 – Dofetilide
Dofetilide .125 mg/1 · Capsule · Oral
Product NDC16729-490
Product details
- Brand name
- Dofetilide
- Generic name
- Dofetilide
- Labeler
- Accord Healthcare, Inc.
- Dosage form
- Capsule
- Route
- Oral
- Marketing category
- ANDA · ANDA213338
- Marketed since
- August 20, 2020
- Listing expires
- December 31, 2026
- Pharmacologic class
- Antiarrhythmic
Active ingredients
- Dofetilide .125 mg/1
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 16729-490-12 | 60 CAPSULE in 1 BOTTLE (16729-490-12) | Aug 20, 2020 |
Recalls mentioning this NDC
- D-0385-2023 Mar 8, 2023 · Class II
CGMP Deviations: recalling drug products following an FDA inspection. - D-0384-2023 Mar 8, 2023 · Class II
CGMP Deviations: recalling drug products following an FDA inspection. - D-0383-2023 Mar 8, 2023 · Class II
CGMP Deviations: recalling drug products following an FDA inspection.
Other Dofetilide products
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- 75907-056 Dofetilide .125 mg/1 · Capsule · Dr. Reddy's Labratories Inc.
- 75907-054 Dofetilide .5 mg/1 · Capsule · Dr. Reddy's Labratories Inc.
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- 76282-755 Dofetilide .125 mg/1 · Capsule · EXELAN PHARMACEUTICALS, INC.