NDC 67877-624 – Dabigatran Etexilate
Dabigatran Etexilate Mesylate 110 mg/1 · Capsule, Coated Pellets · Oral
Product NDC67877-624
Product details
- Brand name
- Dabigatran Etexilate
- Generic name
- Dabigatran Etexilate
- Labeler
- Ascend Laboratories, LLC
- Dosage form
- Capsule, Coated Pellets
- Route
- Oral
- Marketing category
- ANDA · ANDA208040
- Marketed since
- September 12, 2025
- Listing expires
- December 31, 2027
- Pharmacologic class
- Direct Thrombin Inhibitor
Active ingredients
- Dabigatran Etexilate Mesylate 110 mg/1
Uses, dosage, side effects and warnings for Dabigatran Etexilate →
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 67877-624-31 | 10 BLISTER PACK in 1 CARTON (67877-624-31) / 6 CAPSULE, COATED PELLETS in 1 BLISTER PACK | Sep 12, 2025 |
| 67877-624-60 | 60 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-624-60) | Sep 12, 2025 |
Recalls mentioning this NDC
- D-0129-2025 Dec 18, 2024 · Class II
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit - D-0130-2025 Dec 18, 2024 · Class II
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit - D-0533-2023 Apr 5, 2023 · Class II
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit. - D-0534-2023 Apr 5, 2023 · Class II
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
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