Dabigatran Etexilate
- Product NDC
- 67877-624
- 11-digit product format
- 678770624
- Labeler code
- 67877
- Product ID
- 67877-624_dd84fc7b-8d68-4a2b-ab48-9458f6586160
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dabigatran Etexilate
- Dosage form
- CAPSULE, COATED PELLETS
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA208040
- Marketing category
- ANDA
- Marketing start
- 2025-09-12
- Substance
- DABIGATRAN ETEXILATE MESYLATE
- Active strength
- 110 mg/1
- Pharmacologic classes
- Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| SC7NUW5IIT | DABIGATRAN ETEXILATE MESYLATE | 872728-81-9 | DABIGATRAN ETEXILATE MESYLATE |
| 2E18WX195X | DABIGATRAN ETEXILATE | 211915-06-9 | Dabigatran Etexilate |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 67877-624-31 | 67877062431 | 10 BLISTER PACK in 1 CARTON (67877-624-31) / 6 CAPSULE, COATED PELLETS in 1 BLISTER PACK | 10 blister pack | 2025-09-12 | No | No | Historical |
| 67877-624-60 | 67877062460 | 60 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-624-60) | | 2025-09-12 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Dabigatran Etexilate | Ascend Laboratories, LLC | Alkem Laboratories Limited | 2025-09-17 | Human Prescription Drug Label | 26 |