DABIGATRAN ETEXILATE
- Product NDC
- 59651-973
- 11-digit product format
- 596510973
- Labeler code
- 59651
- Product ID
- 59651-973_4b36f34b-c19b-497d-9dd6-5c50404226c5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DABIGATRAN ETEXILATE
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA208039
- Marketing category
- ANDA
- Marketing start
- 2025-05-14
- Substance
- DABIGATRAN ETEXILATE MESYLATE
- Active strength
- 75 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 | 75 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 |
|---|
| 59651-973-60 | DABIGATRAN ETEXILATE | 60 in 1 BOTTLE | CAPSULE | 60 | | 3 |
| 59651-973-61 | DABIGATRAN ETEXILATE | 6 in 1 BLISTER PACK | CAPSULE | 6 | | 3 |
| 59651-973-61 | DABIGATRAN ETEXILATE | 10 in 1 CARTON | CAPSULE | 10 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-973 | DABIGATRAN ETEXILATE CAPSULE [AUROBINDO PHARMA LIMITED] | 1 | Current NDC, 3 package rows | 20250522_5b196b1f-408e-4615-b980-9f822adff835.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 |
|---|
| 59651-973-60 | 59651097360 | 60 CAPSULE in 1 BOTTLE (59651-973-60) | 60 capsule | 2025-05-14 | No | No | Historical |
| 59651-973-61 | 59651097361 | 10 BLISTER PACK in 1 CARTON (59651-973-61) / 6 CAPSULE in 1 BLISTER PACK | 10 blister pack | 2025-05-14 | No | No | Historical |