Dabigatran Etexilate
- Product NDC
- 0378-0266
- 11-digit product format
- 003780266
- Labeler code
- 0378
- Product ID
- 0378-0266_6c6b985e-111f-4fe9-a1ca-785c450e444b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dabigatran Etexilate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA208067
- Marketing category
- ANDA
- Marketing start
- 2025-02-25
- Substance
- DABIGATRAN ETEXILATE MESYLATE
- Active strength
- 150 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 |
|---|
| 0378-0266-91 | 00378026691 | 60 CAPSULE in 1 BOTTLE, PLASTIC (0378-0266-91) | 60 capsule | 2025-02-25 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Dabigatran Etexilate | Mylan Pharmaceuticals Inc. | 2025-07-30 | HUMAN PRESCRIPTION DRUG LABEL | 4 |