DABIGATRAN
- Product NDC
- 50090-7530
- 11-digit product format
- 500907530
- Labeler code
- 50090
- Product ID
- 50090-7530_ecdaf715-da31-4060-95db-557051f3313c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DABIGATRAN ETEXILATE
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA213879
- Marketing category
- ANDA
- Marketing start
- 2024-05-22
- 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 |
|---|
| 50090-7530-0 | DABIGATRAN | 60 in 1 BOTTLE | CAPSULE | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-7530 | DABIGATRAN (DABIGATRAN ETEXILATE) CAPSULE [A-S MEDICATION SOLUTIONS] | 1 | Current NDC, 1 package rows | 20250417_e4e3b992-621a-43a5-be59-eeb5083fd2b4.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 |
|---|
| 50090-7530-0 | 50090753000 | 60 CAPSULE in 1 BOTTLE (50090-7530-0) | 60 capsule | 2025-04-07 | No | No | Historical |