DABIGATRAN
- Product NDC
- 50268-200
- 11-digit product format
- 502680200
- Labeler code
- 50268
- Product ID
- 50268-200_43cbae6c-3c71-51aa-e063-6394a90a6d9a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DABIGATRAN ETEXILATE
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- AvPAK
- Application
- ANDA213879
- Marketing category
- ANDA
- Marketing start
- 2025-07-12
- 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
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50268-200-11 | DABIGATRAN | 1 in 1 BLISTER PACK | CAPSULE | 1 | | 2 |
| 50268-200-16 | DABIGATRAN | 60 in 1 BOX | CAPSULE | 60 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50268-200-11 | 50268020011 | 1 in 1 BLISTER PACK | | | | | Historical |
| 50268-200-16 | 50268020016 | 60 BLISTER PACK in 1 BOX (50268-200-16) / 1 CAPSULE in 1 BLISTER PACK (50268-200-11) | 60 blister pack | 2025-07-12 | No | No | Historical |