DABIGATRAN
- Product NDC
- 42291-033
- 11-digit product format
- 422910033
- Labeler code
- 42291
- Product ID
- 42291-033_484c020e-2b6b-98c8-e063-6294a90a1a73
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DABIGATRAN ETEXILATE
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA213879
- Marketing category
- ANDA
- Marketing start
- 2024-11-27
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DABIGATRAN
- Listing expiration
- 2027-12-31
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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42291-033-60 | DABIGATRAN | 60 in 1 BOTTLE | CAPSULE | 60 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42291-033 | DABIGATRAN (DABIGATRAN ETEXILATE) CAPSULE [AVKARE] | 1 | Current NDC, 1 package rows | 20241205_27e95caf-7938-ef8e-e063-6394a90a6a1a.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 |
|---|
| 42291-033-60 | 42291003360 | 60 CAPSULE in 1 BOTTLE (42291-033-60) | 60 capsule | 2024-11-27 | No | No | Current |