Dabigatran Etexilate
- Product NDC
- 72603-239
- 11-digit product format
- 726030239
- Labeler code
- 72603
- Product ID
- 72603-239_450cc975-a89f-2a41-e063-6394a90aefcf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dabigatran Etexilate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- NorthStar RxLLC
- Application
- ANDA207961
- Marketing category
- ANDA
- Marketing start
- 2025-12-01
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72603-239-01 | Dabigatran Etexilate | 60 in 1 BOTTLE | CAPSULE | 60 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72603-239-01 | 72603023901 | 60 CAPSULE in 1 BOTTLE (72603-239-01) | 60 capsule | 2025-12-01 | No | No | Current |