Dabigatran Etexilate
- Product NDC
- 46708-635
- 11-digit product format
- 467080635
- Labeler code
- 46708
- Product ID
- 46708-635_4f8d4596-bc1a-48a1-8f6a-caf816a2037f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dabigatran Etexilate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA215233
- Marketing category
- ANDA
- Marketing start
- 2024-08-13
- Substance
- DABIGATRAN ETEXILATE MESYLATE
- Active strength
- 110 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 | 110 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 |
|---|
| 46708-635-06 | Dabigatran Etexilate | 10 in 1 CARTON | CAPSULE | 10 | | 3 |
| 46708-635-06 | Dabigatran Etexilate | 6 in 1 BLISTER PACK | CAPSULE | 6 | | 3 |
| 46708-635-60 | Dabigatran Etexilate | 60 in 1 BOTTLE | CAPSULE | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-635 | DABIGATRAN ETEXILATE CAPSULE [ALEMBIC PHARMACEUTICALS LIMITED] | 2 | Current NDC, 3 package rows | 20240817_13649035-a498-4e31-a7ea-8b18cedceca7.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 |
|---|
| 46708-635-06 | 46708063506 | 10 BLISTER PACK in 1 CARTON (46708-635-06) / 6 CAPSULE in 1 BLISTER PACK | 10 blister pack | 2024-08-13 | No | No | Current |
| 46708-635-60 | 46708063560 | 60 CAPSULE in 1 BOTTLE (46708-635-60) | 60 capsule | 2024-08-13 | No | No | Current |