Dabigatran etexilate
- Product NDC
- 43598-453
- 11-digit product format
- 435980453
- Labeler code
- 43598
- Product ID
- 43598-453_e9e8ec3b-2d7e-31cc-6268-60e4da2236ba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dabigatran etexilate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Dr.Reddys Laboratories Inc
- Application
- ANDA208048
- Marketing category
- ANDA
- Marketing start
- 2025-02-28
- 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 |
|---|
| 43598-453-60 | Dabigatran etexilate | 60 in 1 BOTTLE | CAPSULE | 60 | | 21 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-453 | DABIGATRAN ETEXILATE CAPSULE [DR.REDDYS LABORATORIES INC] | 20 | Current NDC, 1 package rows | 20250228_a608e019-db9a-d6fb-cd0d-cecc1351a2b1.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 |
|---|
| 43598-453-60 | 43598045360 | 60 CAPSULE in 1 BOTTLE (43598-453-60) | 60 capsule | 2025-02-28 | No | No | Current |