Dabigatran Etexilate
- Product NDC
- 0904-7255
- 11-digit product format
- 009047255
- Labeler code
- 0904
- Product ID
- 0904-7255_869fd2f3-9357-4148-8b64-0cca96dd5f75
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dabigatran Etexilate
- Dosage form
- CAPSULE, COATED PELLETS
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA208040
- Marketing category
- ANDA
- Marketing start
- 2025-06-23
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dabigatran Etexilate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DABIGATRAN ETEXILATE MESYLATE | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SC7NUW5IIT |
| Rxcui | 1037045, 1037179, 1723476 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-7255-10 | Dabigatran Etexilate | 2 in 1 CARTON | CAPSULE, COATED PELLETS | 2 | | 2 |
| 0904-7255-35 | Dabigatran Etexilate | 10 in 1 BLISTER PACK | CAPSULE, COATED PELLETS | 10 | | 2 |
| 0904-7255-68 | Dabigatran Etexilate | 6 in 1 CARTON | CAPSULE, COATED PELLETS | 6 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7255 | DABIGATRAN ETEXILATE CAPSULE, COATED PELLETS [MAJOR PHARMACEUTICALS] | 1 | Current NDC, 3 package rows | 20250515_b76b79ce-b7dd-4390-b40e-71ae6c477d10.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0904-7255-10 | 00904725510 | 2 BLISTER PACK in 1 CARTON (0904-7255-10) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0904-7255-35) | 2 blister pack | 2025-06-23 | No | No | Current |
| 0904-7255-35 | 00904725535 | 10 in 1 BLISTER PACK | | | | | Historical |
| 0904-7255-68 | 00904725568 | 6 BLISTER PACK in 1 CARTON (0904-7255-68) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0904-7255-35) | 6 blister pack | 2025-06-23 | No | No | Current |