Dabigatran Etexilate
- Product NDC
- 50090-7657
- 11-digit product format
- 500907657
- Labeler code
- 50090
- Product ID
- 50090-7657_18170616-bb47-48f0-b693-17de14a3c970
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dabigatran Etexilate
- Dosage form
- CAPSULE, COATED PELLETS
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA208040
- Marketing category
- ANDA
- Marketing start
- 2022-06-20
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-7657-0 | 50090765700 | 60 CAPSULE, COATED PELLETS in 1 BOTTLE (50090-7657-0) | 2025-09-18 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Dabigatran Etexilate | A-S Medication Solutions | 2025-09-19 | Human Prescription Drug Label | 1 |